BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1851946 · Received September 23, 2010

    Report

    Report Number
    1218950-2010-01686
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 25, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE AC INLET HAD PULLED OUT OF THE MODULE AND THAT THE MODULE FAILED. THE CUSTOMER WAS SENT A NEW AC POWER MODULE WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC INLET HAD PULLED OUT OF THE MODULE AND THAT THE MODULE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M3539A D 0730 C

    Patients

    Seq Age Sex Outcome Treatment
    1