Ann Geraghty

Philips Healthcare 

Mr. Adam Hodson 
Coroner’s Court 
Birmingham & Solihull Districts 
50 Newton Street 
Birmingham 4B 6NE 
Great Britain  

October 8, 2021    

Product = 866389 Patient Information Center iX (PIC iX) / MX40 Telemetry 
Serial Number = 7COD-02P6-V / U5096A7490 

Dear Mr. Hodson, 

Thank  you  for  bringing  to  our  attention  the  incident  involving  the  above  cited  product.  The  complaint 
details, subsequent investigation and resultant findings are described below.  

Incident as reported to Philips Healthcare: 

On August 27, 2021, Philips received the Coroner’s report titled ‘Regulation 28 Report to Prevent Future 
Deaths ’ issued by you, Adam Hodson, HM Assistant Coroner. The following was reported: 

“On 1 April  2021 I commenced an investigation into the death of [redacted]. The investigation 
concluded at the end of the inquest. The conclusion of the inquest was: Death was a consequence 
of natural causes. 

The deceased was admitted to Good Hope Hospital on 26 February 2021 where [redacted] was 
treated for heart failure. [Redacted] was commenced on continual cardiac monitoring from 6th to 
8th March, where two periods of ventricular standstill were recorded but were missed due to a 
combination of policy, staffing, workplace and equipment issues. [Redacted] suffered a cardiac 
arrest on 8 March 2021 and was treated on ICU for 22 days in total. Despite treatment, [redacted] 
deteriorated rapidly on [redacted] final day, and [redacted] died at 13:40, 30 March 2021. Had the 
periods of ventricular standstill been detected, [redacted] would have been admitted to CCU for 
monitoring, but [redacted] subsequent cardiac arrests could not have been prevented.” 

The report summarized concerns of a risk that future deaths will occur unless action is taken. Specifically, 
the report discussed a retrospective review of the telemetry monitoring carried out on this patient during 
the period of March 6-8, 2021. Two periods of ventricular standstill were noted: one at 12:43 on March 6, 
2021 where the telemetry  recorded  a period of 4 seconds  of ventricular standstill; and one at 13:09  on 
March 8, 2021 where the telemetry recorded a period of 10 seconds of ventricular standstill. The report 
further indicated that Medical Engineers were asked to analyse the telemetry and noted that on March 8, 
2021 the monitor's alarm had triggered and that it was a self-terminating alarm as the heart rhythm had 
corrected itself. Medical Engineers and staff indicated there was no evidence that staff muted the alarm or 
that there was any fault with the equipment. Thus, it was concluded per the report that this self-correcting 
function is an intended function of the monitor. 

 
 Philips Healthcare 

Investigation: 

Strip Review 
As the Device Manufacturer, Philips’ first contact from the Hospital in regard to this incident was on June 
29, 2021. This was an informal request to investigate to a Philips Clinical Application Specialist (CAS) 
whilst  visiting  Heartlands  Hospital  on  another  matter.  The  question  from  the  Matron  was  whether  a 
Ventricular Standstill would cause an alarm and, if so, how long it would last for. A general ECG waveform 
strip and an Asystole Alarm strip, printed out around the time of the incident, was emailed to the CAS on 
July  18,  2021.  The  Asystole  Alarm  strip  showed  this  alarm  generated  at  the  time  of  the  Ventricular 
Standstill,  but  without  the  Clinical  Audit  Logs,  the  duration  of  this  alarm  and  any  other  actions  taken 
around the time of this alarm are unknown.   

The configuration of the PIC iX was reviewed by the CAS at the time of this first site visit and found the 
systems  functioning  as  designed.  Red  alarms  were  enabled  and  cannot  be  terminated  without  end  user 
intervention.  

Further review of the available information found that there was not a strip for the incident on March 6, 
2021 to review. A strip was provided for March 8, 2021 13:09:13 that revealed an ECG waveform with 
beat labels. A (artifact), M (missed), ? (questionable), and one beat labeled N (normal) along with a period 
of ventricular standstill. The strips do not include the response taken by the user nor the length of time the 
alarm  sounded.  Philips  was  not  notified  of  the  March  2021  incidents  until  greater  than  three  months 
following the events.  As a result, Clinical Audit Logs required for a complete investigation were no longer 
available.  

Self-Terminating Alarms 
Per the report, hospital Medical Engineers were asked to review the Telemetry and the hospital Medical 
Engineers noted that on March 8, 2021, the monitors alarm had triggered and that it was a self-terminating 
alarm.  Philips  is  interpreting  this  description  as  the  alarm  stopped  on  its  own  accord  without  user 
interaction. Any ventricular standstill of 4-10 seconds of duration would meet the definition of Asystole 
which  is  a  red  arrhythmia  alarm.  There  is  not  a  configuration  to  change  Asystole  or  any  other  red 
arrhythmia alarm to self-terminate for a Telemetry / Central Station setup. In summary, the product is not 
designed to self-terminate red alarms nor is Philips able to reproduce the described behavior. 

Good Hope Hospital Site Visit 
Philips support personnel performed a site visit to Good Hope Hospital on September 24, 2021. 

An ECG simulator was utilized to test the customer’s system using the same equipment that was used on 
the patient in March.  An Asystole alarm was generated, and the simulator was reset to normal sinus rhythm 
and the alarm continued even though the asystole condition had ended. Testing revealed no self-terminating 
of alarms. The devices were found to perform as expected. 

The configuration was further reviewed by the Business Unit Clinical Specialist from the data collected 
during this site visit and the initial assessment of red alarms cannot be terminated without intervention was 
verified.  While the original description of the issue was reported as the Information Center iX; this issue 
is with alarm detection and communication from the Telemetry to the PIC iX.  When Telemetry is used 
with PIC iX, the alarm settings are sent from the PIC. Red alarms cannot be set to self terminate in the PIC 
configuration.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Philips Healthcare 

Complaint Review 
Complaints were analyzed for the last 3 years world-wide and found one other similar complaint. This 
complaint was a non-adverse event, it was found that the alarm had been silenced by an end user initially 
and  was  giving  an  alarm  reminder  with  brief  audible  alerts  since  alarm  reminders  were  enabled.  The 
equipment was operating as designed. 

Conclusion: 

Philips  Healthcare  investigated  the  reported  incident  and  concluded  that  the  device  operates  per 
specification.  

•  A full investigation into the alleged self-terminating alarm incident was not possible as the required 

logs were not obtained when the incident occurred. 

•  There is not a configuration available to enable asystole or any other red arrhythmia alarm to self-

terminate for Telemetry / Central Station monitoring. 

•  Termination of asystole or other red arrythmia alarm with the current configuration requires end 

user intervention, as shown with the simulation test with NHS personnel present.  

•  Based on the current configurations of the system, if a red alarm is silenced by the user but persists, 
the expected behavior is for the audible alarm to end, the visual alarm to remain and a brief series 
of audible tones to be provided every 3 minutes, which stop after several seconds on their own as 
long as the condition remains. 

•  An on-site visit found the equipment to be operating as designed. 

 A full explanation of the configuration options is available in the Configuration Guide.  Philips’ clinical    
 support continues to be available to assist with any changes to desired workflow. 

 Please be assured that Philips Healthcare is committed to providing quality products and solutions. If you  
 have any questions on the investigation of this incident, please contact us.  

Sincerely, 

Philips Healthcare  
Complaint Investigator 
Quality and Regulatory 
One Deerfield Centre 
13560 Morris Road 
Alpharetta, GA 30004 

Cc:  Good Hope Hospital 

Quality Manager 
Philips Electronics UK Limited 
Philips Centre, Ascent 1  
Aerospace Blvd 
Farnborough, GU14 6XW

For the attention of Mr Adam Hodson 
Assistant Coroner for Birmingham and Solihull 
50 Newton Street 
Birmingham 

18 October 2021 

Dear Mr Hodson 

Inquest touching the death of Anne Geraghty 
Inquest – 25 August 2021 

I write further to the Inquest touching the death of Anne Geraghty in which you issued a Regulation 
28 Report to Prevent Future Deaths to Philips in relation to their central monitoring stations. 

Following receipt of the Report, a meeting took place with our clinical leads and representatives from 
Philips  to  discuss  the  equipment  and  the  issues  that  had  arisen  in  this  case.    Philips  have  also 
subsequently attended and undertaken an inspection of the specific machine used in monitoring Ms 
Geraghty.  

During  the  Inquest,  the  evidence  presented  to  you  in  both  our  internal  investigation  and  through 
witness evidence, was that the alarms on the monitoring equipment had self-terminated.  This was 
based on evidence obtained from nursing staff and our medical engineering team that the alarm had 
not been silenced and therefore it was assumed that it had self-terminated on Ms Geraghty’s heart 
rhythm returning to normal.  

During our discussions with Philips subsequent to the Inquest Hearing we have become aware that 
the machines are not configured in a way that allows alarms to self-terminate upon the heart rhythm 
returning to normal.  The alarm must therefore have been silenced and we believe this is likely to have 
been a user error based on the fact the trace would have shown a normal rhythm within seconds of 
the  alarm  sounding.    In  light  of  this  information,  we  would  like  to  apologise  for  our  honest  and 
mistaken belief that the alarms on the equipment self-terminated.  From our subsequent enquiries it 
appears  that  the  confusion  as  to the  functionality  of  the  equipment  is  likely  to  have  arisen  during 
conversations  with  our  ward  staff  and  medical  engineers,  and  subsequently  with  Philips’s  support 
personnel. There is no evidence of any deliberate provision of incorrect information.  

As stated above, it is considered most likely that a member of staff must have silenced the alarm, 
noted  that  the  heart  was  in  normal  rhythm  and  took  no  further  action.    Once  an  alarm  has  been 
silenced, the configuration of the equipment does not automatically highlight the abnormal section of 

 
 the ECG and therefore no further action was taken at that point.  It was only on a later examination of 
the log that the episode became apparent.    Our clinical evidence remains that this episode, and the 
failure  to  identify  the  same  at  the  time,  would  not  have  affected  the  outcome  as  regards  Ms 
Geraghty’s unfortunate death. 

Action Plan 

As soon as we became aware of the machine configuration, following the inspection undertaken by 
Philips, we took a number of immediate steps to raise awareness of the alarm system in place which 
included an email to all cardiology staff on each of our sites detailing how the alarm system 
functions.  This information was also discussed in ward safety huddles.   

In addition to the above, we have also put in place a number of other actions as set out below. 

Education and training 

In  addition  to  internal  education,  the  Trust  is  working  with  Philips  to  provide  additional  refresher 
training and education to our staff around the monitoring equipment and relevant human factors in 
the management of the same, including efforts to avoid/minimise any risk of ‘alarm fatigue’.  This will 
include an Alarm Management Programme across our cardiology service at all our sites.  

Both our divisional and medical device team educators will be involved with the refresher  training, 
and  we  are currently  in  discussion  with  Philips  to  agree  dates.    Our  aim  is  to have  completed the 
education and training within the next 3 months.  

Machine configuration 

As set out above, once an alarm is silenced, there is no facility which allows for the immediate 
review of the abnormal ECG if no longer on view.  In partnership with Philips, we will be exploring 
whether it is possible to alter the configuration of the software and to explore with them the 
possibility of putting in place a facility which allows for review of the abnormal section of the ECG at 
the point it is silenced.   

Retention of traces 

Currently trace logs are only retained for a period of 50 days before they are removed from the 
system.  In this case, the traces had already been removed at the point where Philips were asked to 
review them and so this could not assist the authors of the SI report relied upon at the Inquest 
Hearing.  In recognition of this issue the Trust is exploring the retention of trace logs locally for an 
extended period which would allow for retrospective review. 

I would like to assure you that we have reflected on this case and have taken immediate steps to 
ensure our teams are fully aware of how the alarm systems function on the monitoring equipment.  
We will continue to work with Philips and implement the actions set above which we hope provides 
you with assurance that steps are being taken to prevent any similar occurrences in the future.  

Once again, we apologise to both the Court and the parties for the inadvertent incorrect evidence 
provided.  This has been reflected on within both the Service and the Trust’s legal department and 
we can assure you that reflection on this incident will ensure increased scrutiny of evidence before it 
is provided to your office. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Yours sincerely, 

Chief Medical Officer 
University Hospitals Birmingham NHS Foundation Trust