BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 1983703 · Received February 3, 2011

    Report

    Report Number
    1218950-2011-00311
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 UNIT FAILED TO CHARGE THE BATTERY. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND EVALUATED THE UNIT. THE FAILURE WAS FURTHER DETERMINED TO BE THAT WHEN THE BATTERY WAS INSERTED INTO THE UNIT THE UNIT WOULD UNEXPECTEDLY SHUTDOWN. REPLACEMENT OF THE BATTERY RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO CHARGE THE BATTERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1