BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2980973 · Received February 4, 2013

    Report

    Report Number
    1218950-2013-00385
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    December 10, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE BATTERY WON'T HOLD A CHARGE, STOPS WORKING AND MACHINE KNOCKS POWER OUT. THERE WAS NO REPORTED PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY WON'T HOLD A CHARGE, STOPS WORKING AND MACHINE KNOCKS POWER OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47460 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1