• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Patient Problem Cardiac Arrest (1762)
Event Date 04/09/2018
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that the device analysis in aed mode did not recognize ventricular fibrillation (vf) and issued a no shock advised message. The customer reported the following information: on (b)(6) 2018 at 11:05 am a (b)(6) male, weight (b)(6), was treated by paramedics indoor at the department of motor vehicles (dmv) for cardiac arrest on the floor. Cardiopulmonary resuscitation (cpr) was initiated by an off-duty paramedic prior to the crews arrival. The patient was connected to the device and set in aed mode at 11:07 am. The mrx failed to recognize a shockable rhythm at 11:09:31. Paramedics did not change their efforts based on the no-shock prompt, they continued cpr for two minutes per their protocol.
 
Manufacturer Narrative
Problem statement: it was reported to philips that the device analysis in aed mode did not recognize ventricular fibrillation (vf) and issued a no shock advised message. Device evaluation: the customer requested that a philips field service engineer (fse) be dispatched to the customer site. The fse was instructed to reload software and pull logs to submit to ccsc. A) how evaluated (actual, simulator, similar)? the fse evaluated the device onsite. B) reproduced? unknown c) correct use? yes d) evaluation results (if applicable): t6 software was at fault. Patient/user involvement:: the customer reported the following information: on (b)(6)2018 at (b)(6)am a (b)(6)year old male, weight (b)(6)kg, was treated by paramedics indoor at the department of motor vehicles (dmv) for cardiac arrest on the floor. Cardiopulmonary resuscitation (cpr) was initiated by an off-duty paramedic prior to the crews arrival. The patient was connected to the device and set in aed mode at 11:07 am. The mrx failed to recognize a shockable rhythm at 11:09:31. Paramedics did not change their efforts based on the no-shock prompt, they continued cpr for two minutes per their protocol. Users did not identify that the mrx had failed to identify a shockable rhythm (interpretation is outside their scope of practice). The issue was identified by reviewers doing routine quality assurance following the event. It is unlikely that the patient outcome was attributed to the device behavior, but it is possible (albeit unlikely) that the patient may have had a more favorable outcome had the rhythm been shocked by the mrx earlier. Final patient disposition is unknown, but at time of transfer of care, the patient had regained a pulse. A) relationship between device and incident? the device was in aed mode during use. B) how was device in use? the device was being used to treat a patient in cardiac arrest. C) patient condition at time of event (if applicable)? the patient was in cardiac arrest. D) patient data evaluation: see the above information provided by the customer. Resolution and disposition: the t6 software was reloaded. A) how was issue resolved? the fse uploaded the t6 software. B) where is device now? the device passed all performance assurance testing and was placed back in service. C) what parts replaced/why, if known? none historical data review: trending: in the past 12 months, there were 9 other cases (approximate average of less than 1 per month) of software related problems. The serial numbers indicate a large span of manufacturing dates. None of the 9 complaints involved serious injury (si) or death. This is a variably occurring issue with no indication of increase or causing or contributing to serious injury or death and no further investigation or action are warranted. Corrective action: a) action necessary, why/why not? no b) any similar capa/fco or sb? no conclusion: this was a malfunction of the t6 software. Customer communication: the customer has requested and will receive communication regarding the results of the investigation.
 
Event Description
It was reported to philips that the device analysis in aed mode did not recognize ventricular fibrillation (vf) and issued a no shock advised message. The device was being used in the aed mode on a patient in cardiac arrest. Upon review of the event file as part of quality assurance activities performed by the customer after the event occurred, the customer had questions about the first shock advisory decision. Philips considers this event as a serious injury as the reported symptom occurred during cardiac arrest.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTSTART MRX -EMS DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7501355
MDR Text Key107820898
Report Number1218950-2018-04217
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Device Catalogue NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
-
-