BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 4250321 · Received November 6, 2014

    Report

    Report Number
    1218950-2014-06718
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE WILL NOT CHARGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714950 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A 39-2013 X 2 33-2013 X 2

    Patients

    Seq Age Sex Outcome Treatment
    1