BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR

    MDR report key: 3102054 · Received April 22, 2013

    Report

    Report Number
    1218950-2013-01403
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING A ROUTINE DAILY TEST, THE CUSTOMER DISCOVERED THAT THE INTERNAL PADDLES DID NOT WORK. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER CONTACTED PHILIPS AND WAS ADVISED TO PERFORM THE CONTINUITY TEST. THE TEST FAILED. THE CUSTOMER DETERMINED THAT THE INTERNAL PADDLE SET HAD FAILED. THE CUSTOMER REPLACED THE INTERNAL PADDLE SET TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    DURING A ROUTINE DAILY TEST, THE CUSTOMER DISCOVERED THAT THE INTERNAL PADDLES DID NOT WORK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171787 INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS M4742A

    Patients

    Seq Age Sex Outcome Treatment
    1