BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-LON BATTERY

    MDR report key: 2080134 · Received April 6, 2011

    Report

    Report Number
    1218950-2011-00922
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE AND THE UNIT FAILED TO POWER UP WITH THIS BATTERY INSERTED. THERE WAS NO REPORT OF PT INVOLVEMENT. THE BATTERY WAS EVALUATED AT PHILIPS AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE BATTERY RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE AND THE UNIT FAILED TO POWER UP WITH THIS BATTERY INSERTED. 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-LON BATTERY MKJ PHILIPS HEALTHCARE M3538A 1029-209-P

    Patients

    Seq Age Sex Outcome Treatment
    1