BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2102599 · Received May 20, 2011

    Report

    Report Number
    1218950-2011-01424
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT UNIT UNEXPECTEDLY SHUT DOWN WHILE MONITORING A PT. NO ADVERSE PT IMPACT WAS REPORTED. THE DEVICE WAS EVALUATED BY PHILIPS AND NO PROBLEM WAS IDENTIFIED. THE ISSUE WAS LOCALIZED BY THE CUSTOMER TO THE EXTERNAL AC/DC CONVERTER WHICH POWERS THE UNIT IN THE AMBULANCE. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UNIT UNEXPECTEDLY SHUT DOW WHILE MONITORING A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR