BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4930865 · Received July 22, 2015

    Report

    Report Number
    3015876-2015-00884
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 25, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. FOLLOWING REPAIR, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A DIODE, DESIGNATOR CR30 BEING SHORTED FROM PIN 5 TO 9. THIS DIODE, DESIGNATOR CR30 ON THE THERAPY PCB ASSEMBLY BEING SHORTED FROM PIN 5 TO 9, CAUSED THE DEVICE TO DELIVER MONOPHASIC DEFIBRILLATION SHOCKS ONLY AND PACING PULSES TO BE IRREGULAR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE DID NOT PASS ITS SELF-TEST. DURING DEVICE EVALUATION, PHYSIO-CONTROL OBSERVED THAT THE DEVICE HAD LOGGED MULTIPLE EVENT CODES INTO ITS MEMORY. IN ADDITION IT WAS OBSERVED THAT THE DEVICE WOULD ONLY SHOCK MONOPHASIC DEFIBRILLATION ENERGY AND THAT THE ENERGY OUTPUT WOULD BE LESS THAN THE SELECTED ENERGY LEVEL. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475332 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1