BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2233080 · Received July 26, 2011

    Report

    Report Number
    1218950-2011-02132
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPLACED THE AC POWER MODULE TO RESOLVE THE ISSUE. THE AC POWER MODULE WAS NOT AVAILABLE FOR EVALUATION. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE FAILED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE - ANDOVER M3539A 0805

    Patients

    Seq Age Sex Outcome Treatment
    1