BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2083175 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01023
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 16, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER CONNECTOR ON THE AC POWER MODULE POPPED OUT AND WIRES WERE EXPOSED. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER WAS SENT A REPLACEMENT AC POWER MODULE TO RESOLVE THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER CONNECTOR ON THE AC POWER MODULE POPPED OUT AND WIRES WERE EXPOSED. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M3539A 1016

    Patients

    Seq Age Sex Outcome Treatment
    1