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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Loss Of Pulse (2562)
Event Date 01/30/2018
Event Type  Death  
Event Description
It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea). The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode. While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised. The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea. The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident. , but the crash team did not recall hearing these events. The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest. The fse reported that the issue was not confirmed and there was no trouble found with the device. The device passed all performance assurance testing and was placed back in service.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete. Patient information requested, not yet received.
 
Event Description
It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea). The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode. While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised. The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea. The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident. , but the crash team did not recall hearing these events. The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest.
 
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Brand NameHEARTSTART MRX
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
22100 bothell-everett hwy
bldg a
bothell, WA 98021
9786871501
MDR Report Key7241750
MDR Text Key110338883
Report Number1218950-2018-01286
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM3535A
Device Lot Number.
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 Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2005
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: 02/05/2018 Patient Sequence Number: 1
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