BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2041454 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00607
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO PHILIPS CARE THE AC POWER MODULE WAS NOT WORKING. IT WAS EVALUATED LOCALLY BY THE CUSTOMER. GIVEN THE INFO PROVIDED BY THE CUSTOMER, PHILIPS DETERMINED THAT THE AC POWER MODULE HAD FAILED. THE CUSTOMER WAS SENT A NEW ONE WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS THAT THE AC POWER MODULE WAS NOT WORKING. IT WAS EVALUATED LOCALLY BY THE CUSTOMER. GIVEN THE INFO PROVIDED BY THE CUSTOMER, THE PHILIPS CUSTOMER CARE CENTER DETERMINED THAT THE AC POWER MODULE HAD FAILED. THE CUSTOMER WAS SENT A NEW ONE WHICH RESOLVED THE FAILURE. WE WILL CONSIDER THIS A A/C POWER MODULE FAILURE.

    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