BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2080107 · Received April 6, 2011

    Report

    Report Number
    1218950-2011-00921
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. ON (B)(6) 2011, THE CUSTOMER CLARIFIED THAT THE DEVICE FAILED TO POWER UP VIA BATTERY POWER. THE CUSTOMER WAS SENT A REPLACEMENT BATTERY. WE ARE CONSIDERING THIS A MALFUNCTION OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A 1030-066-P REV J

    Patients

    Seq Age Sex Outcome Treatment
    1