BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2941978 · Received December 22, 2012

    Report

    Report Number
    1218950-2012-04230
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    November 26, 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 FSE ISOLATED THE ISSUE TO THE BATTERY. THE AGE OF THE BATTERY WAS UNKNOWN. THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO USE. WE WILL CONSIDER THIS A MALFUNCTION OF THE BATTERY WHERE THE DEVICE SHUT DOWN. AS OF (B)(4) 2012 THE CUSTOMER CONFIRMED THE DEVICE IS NOW WORKING FINE AND HAS NO MORE ISSUES.

    Description of Event or Problem · 1

    THE PHILIPS FIELD SERVICE ENGINEER WAS EVALUATING A DEVICE FOR AN OP CHECK HANG PROBLEM ADDRESSED IN (B)(4) WHERE AN ADDITIONAL FAILURE WAS OBSERVED. A DEAD BATTERY WAS FOUND TO ONLY HOLD A CHARGE FOR FEW MINUTES THEN THE DEVICE SHUTDOWN. THERE WAS NO PT INVOLVEMENT WHERE THIS OCCURRED DURING SERVICING.

    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