BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 1934553 · Received December 3, 2010

    Report

    Report Number
    1218950-2010-02474
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 8, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PADDLE SET CABLE HAD A CUT IN THE CASING AND THAT THE UNIT SHOWED A RED X AFTER PASSING THE OPCHECK TEST. DUE TO THE PADDLE SET NOT BEING TESTED PRIOR TO DISPOSAL, WE CANNOT DETERMINE IF THE PADDLE SET WAS CAPABLE OF DELIVERING THERAPY. THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS FIELD SERVICE ENGINEER AND THE FAILURE WAS VERIFIED. REPLACING THE PADDLES SET RESOLVED THE FAILURE. THE UNIT REMAINS AT THE CUSTOMER SITE WITH THE NEW PADDLE SET INSTALLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADDLE SET CABLE HAD A CUT IN THE CASING AND THAT THE UNIT SHOWED A RED X AFTER PASSING THE OPCHECK TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PADDLES MKJ PHILIPS HEALTHCARE M3542A

    Patients

    Seq Age Sex Outcome Treatment
    1