BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2471899 · Received February 22, 2012

    Report

    Report Number
    1218950-2012-00607
    Event Type
    Death
    Date Received
    February 22, 2012
    Report Date
    January 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHILE USING THE Q-CPR METER IN THE AED MODE, THE METER WOULD GIVE COMPRESSION DEPTH FEEDBACK BUT NO VOICE COMMANDS. THE CUSTOMER STATED THAT THE Q-CPR METER BEHAVIOR HAD NO IMPACT WITH THE PT OUTCOME. THE USERS CONTINUED TO DELIVER CHEST COMPRESSIONS. THE DEVICE WAS EVALUATED AT THE PHILIPS REPAIR BENCH AND THE REPORTED FAILURE COULD NOT BE RECREATED. THE Q-CPR METER WAS ALSO EVALUATED BY THE PHILIPS AND THERE WAS NO TROUBLE FOUND WITH THE METER. WE CANNOT DETERMINE THE CAUSE AS THE ISSUE COULD NOT BE RECREATED WITH EITHER THE DEVICE OR THE METER. THE DEVICE PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING THE Q-CPR METER IN THE AED MODE, THE METER WOULD GIVE COMPRESSION DEPTH FEEDBACK BUT NO VOICE COMMANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS-DUP M3536A 8011104177-METER

    Patients

    Seq Age Sex Outcome Treatment
    1