BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2072758 · Received March 31, 2011

    Report

    Report Number
    1218950-2011-00867
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Report Date
    March 2, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 CUSTOMER REPORTED THAT THE BATTERY WAS DEPLETING FASTER THAN NORMAL. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE BATTERY WAS COMPLETELY DEPLETED AND WOULD NOT CHARGE. THE UNIT FAILED TO POWER UP ON BATTERY POWER WHEN TESTED. THE CUSTOMER IS ORDERING A NEW BATTERY TO RESOLVE THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS DEPLETING FASTER THAN NORMAL. THERE WAS NO REPORT OF 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 HEALTHCARE M3538A 0915-211-M REV G

    Patients

    Seq Age Sex Outcome Treatment
    1