BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2883696 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00940
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A DIODE, DESIGNATOR CR30, BEING SHORTED FROM PIN 5 TO PIN 9. THIS CAUSED AN EVENT CODE DURING SELF-TEST OF THE DEVICE AND ENERGY TO BE DELIVERED AT ONLY 85% OF THE TARGET ENERGY IN A MONOPHASIC WAVEFORM.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE FUNCTION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO THE PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE FAILED THE SELF-TEST. DURING A DEVICE EVALUATION, PHYSIO-CONTROL OBSERVED THAT THE DEVICE'S MEMORY HAD LOGGED AN EVENT CODE POTENTIALLY AFFECTING DEFIBRILLATION THERAPY AND DURING TESTING, THE DEFIBRILLATION ENERGY VARIED FROM 10 TO 100 JOULES BELOW THE SET VALUE. THE DEFIBRILLATION ENERGY WAS MONOPHASIC INSTEAD OF BIPHASIC. THE DEVICE MAY NOT DELIVER ADEQUATE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1