BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 3012916 · Received February 25, 2013

    Report

    Report Number
    1218950-2013-00680
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    January 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT GETTING POWER. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY THE CUSTOMER WHO LOCALIZED THE PROBLEM TO A FAULTY AC POWER MODULE. THE CUSTOMER ORDERED A NEW AC POWER MODULE TO RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT GETTING POWER. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80120 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A REV D_0631

    Patients

    Seq Age Sex Outcome Treatment
    1