BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1961511 · Received January 10, 2011

    Report

    Report Number
    1218950-2011-00089
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 14, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED TO PHILIPS THAT THE AC INLET WAS PULLED OUT OF THE AC POWER MODULE AND THE WIRES WERE BROKEN. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE AC POWER MODULES HAVE BEEN REPLACED AND THAT THE UNITS ARE BACK IN USE AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE AC INLET WAS PULLED OUT OF THE AC POWER MODULE AND THE WIRES WERE BROKEN.

    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