BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1853720 · Received October 1, 2010

    Report

    Report Number
    1218950-2010-01813
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    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 HAD FAILED. A PHILIPS FSE WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. REPLACING THE AC POWER MODULE RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE. WE WILL CONSIDER THIS FAILURE A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE HAD 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