BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1926408 · Received November 11, 2010

    Report

    Report Number
    1218950-2010-02244
    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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE AC POWER MODULE WAS NOT WORKING. THIS REPORTED ISSUE IS MOST CONSISTENT WITH AN AC POWER MODULE FAILURE. PHILIPS RECOMMENDED TO THE CUSTOMER TO REPLACED THE MODULE. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO COULD NOT CONFIRM IF THE AC POWER MODULE HAD BEEN REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE WAS NOT WORKING.

    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