BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3203605 · Received July 3, 2013

    Report

    Report Number
    3015876-2013-00570
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL THEN REPLACED BOTH THE BIPHASIC AND THERAPY PCB ASSEMBLIES AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED BIPHASIC PCB ASSEMBLY BUT WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO THEN EXAMINED THE THERAPY PCB AND WAS ABLE TO VERIFY THAT THERE WERE MULTIPLE THERAPY RELATED EVENT CODES LOGGED IN TO THE DEVICES MEMORY FOR THE DATE OF THE EVENT; HOWEVER, AFTER EXTENSIVE TESTING OF THE PCB ON MOCK-UP THE REPORTED FAILURE COULD NOT BE DUPLICATED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND EVENT CODES IN THE MEMORY. UPON EXAMINATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE UNIT WOULD CONTINUALLY CHARGE ENERGY FOR ANYTHING SELECTED OVER 100 JOULES, BUT WOULD NEVER DISCHARGE. THE UNIT HAD TO BE TURNED OFF IN ORDER TO TERMINATE THE CHARGE. SUFFICIENT DEFIBRILLATION WAS NOT AVAILABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306553 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1