BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2837346 · Received October 12, 2012

    Report

    Report Number
    1218950-2012-03427
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Report Date
    September 18, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS FIELD SVC ENGINEER REPORTED THE BATTERY WILL NOT HOLD A CHARGE AND THE DEVICE SHUTDOWN UNEXPECTEDLY. THERE WAS NO PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PHILIPS FIELD SVC ENGINEER REPORTED THE BATTERY WILL NOT HOLD A CHARGE AND THE DEVICE SHUT DOWN UNEXPECTEDLY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1