BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2121272 · Received May 4, 2011

    Report

    Report Number
    1218950-2011-01278
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    March 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED 2 OUT OF 3 WIRES WERE BROKEN INSIDE THE A/C MODULE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE CUSTOMER ORDERED A REPLACEMENT AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 OUT OF 3 WIRES WERE BROKEN INSIDE THE A/C MODULE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    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