BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 5112293 · Received September 29, 2015

    Report

    Report Number
    1218950-2015-05230
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    September 4, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYS A LOW BATTERY MESSAGE WHEN THE DEVICE IS PLUGGED INTO AC POWER AND THE BATTERY HAS SUFFICIENT TIME TO CHARGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643176 HEARTSTART SLA BATTERY BATTERY DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1