BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1926391 · Received November 11, 2010

    Report

    Report Number
    1218950-2010-02241
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 14, 2010
    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): IT WAS REPORTED TO PHILIPS THAT THE AC POWER MODULE FAILED. THE UNIT AND AC POWER MODULE WERE EVALUATED AND THE FAILURE WAS VERIFIED. THE AC POWER MODULE WAS REPLACED FROM THE CUSTOMER'S STOCK WHICH RESOLVED THE FAILURE. AS OF 11/8/10, THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE FROM THIS CUSTOMER SITE. THE UNIT REMAINS AT THE CUSTOMER SITE WITH THE NEW MODULE INSTALLED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE AC POWER MODULE FAILED.

    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