BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2233106 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02117
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FILED SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND FOUND THAT THE AC POWER MODULE HAD FAILED SUCH THAT THE INLET WAS PULLED OUT OF THE CASE CAUSING THE BATTERY NOT TO CHARGE. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE WHERE THE CONNECTOR PULLED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1