BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1811463 · Received August 17, 2010

    Report

    Report Number
    1218950-2010-01332
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    July 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE AC POWER MODULE POWER CONNECTION WAS BROKEN. THE AC POWER MODULE WAS REPLACED UNDER WARRANTY WHICH RESOLVED THE FAILURE. 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 POWER CONNECTION WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M359A

    Patients

    Seq Age Sex Outcome Treatment
    1