BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1924979 · Received November 22, 2010

    Report

    Report Number
    1218950-2010-02333
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 28, 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): THE CUSTOMER REPORTED THAT THE AC POWER MODULE FAILED. A PHILIPS REPRESENTATIVE WAS AT THE CUSTOMER SITE. THE AC POWER MODULE WAS TESTED AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE MODULE RESOLVED THE FAILURE. AS OF 11/18/2010, 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

    THE CUSTOMER REPORTED 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