BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1894110 · Received November 4, 2010

    Report

    Report Number
    1218950-2010-02146
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Report Date
    October 7, 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 HAD FAILED. THE CUSTOMER ORDERED AN AC POWER MODULE WHICH RESOLVED THE FAILURE. AS OF (B)(4) 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 HAD FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M3539A F 1008 C

    Patients

    Seq Age Sex Outcome Treatment
    1