BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 2841407 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03544
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY FAILED WHERE THE DEVICE WOULD NOT TURN ON IN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SLA BATTERY DQA MKJ LDD DRO DQA PHILIPS MEDICAL SYSTEMS M3516A R-2012-02

    Patients

    Seq Age Sex Outcome Treatment
    1