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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problems No Device Output (1435); Communication or Transmission Problem (2896)
Patient Problem Death (1802)
Event Date 10/15/2016
Event Type  Death  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that no capnography (etco2) reading was given by the device, showing question marks for the value and the etco2 waveform showed dashed lines. The involved patient was in cardiac arrest. Cpr was initiated by the crew. The customer did not allege that device behavior impacted patient outcome, as they reported that at no time during treatment did a pulse return to the patient.
 
Manufacturer Narrative
An electronic event file from 10/15/2016 at 6:06:43 pm was reviewed and indicates co2 check exhaust inop messages. An etco2 reading was not acquired. The device and accessories were evaluated by a philips field service engineer and the reported symptom was confirmed. The issue was isolated to the malfunction of the etco2 module. The etco2 module was replaced to resolve the issue. The device then passed all required performance verification testing and was placed back into use.
 
Event Description
It was reported to philips that no capnography (etco2) reading was given by the device, showing question marks for the value and the etco2 waveform showed dashed lines. The involved patient was in cardiac arrest. Cpr was initiated by the crew and was continuous throughout the event. Six shocks were delivered to the patient. The customer did not allege that device behavior impacted patient outcome, as they reported that at no time during treatment did a pulse return to the patient.
 
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Brand NameHEARTSTART MRX -EMS DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6093922
MDR Text Key59625706
Report Number1218950-2016-07105
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Paramedic
Type of Report Initial,Followup
Report Date 11/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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