BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1771893 · Received July 22, 2010

    Report

    Report Number
    1218950-2010-01198
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO PHILIPS THAT THIS CUSTOMER FREQUENTLY HAD ISSUES WITH THE AC POWER MODULE INLET PULLING OUT OF THE HOUSING CAUSING A FAILURE TO CHARGE THE BATTERY. THE FAILURE WAS RESOLVED LOCALLY BY PHILIPS BY REPLACING THE AC POWER MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THIS CUSTOMER FREQUENTLY HAD ISSUES WITH THE AC POWER MODULE INLET PULLING OUT OF THE HOUSING CAUSING A FAILURE TO CHARGE THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1