BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1983714 · Received February 3, 2011

    Report

    Report Number
    1218950-2011-00303
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 11, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS EVALUATED LOCALLY BY THE CUSTOMER. GIVEN THE INFORMATION PROVIDED BY THE CUSTOMER, THE LOCAL PHILIPS CUSTOMER CARE CENTER DETERMINED THAT THE AC POWER MODULE HAD FAILED. THE CUSTOMER WAS SENT A REPLACEMENT A/C POWER MODULE, AND THIS RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE LOCAL PHILIPS CUSTOMER CARE CENTER THAT THE AC POWER MODULE WAS ARCING AND PITTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1