BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2920510 · Received January 17, 2013

    Report

    Report Number
    3015876-2013-00053
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    July 5, 2012
    Report Date
    October 22, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. SEVERAL THERAPY RELATED EVENT CODES WERE NOTED TO BE LOGGED IN THE DEVICE. PHYSIO-CONTROL REPLACED THE BIPHASIC AND THERAPY PCB ASSEMBLIES, THE HIGH ENERGY STORAGE CAPACITOR, THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE THERAPY, BIPHASIC AND THE SYSTEM PCB, AND THE ISOLATION RELAY ASSEMBLY. THERE WAS NO ADDITIONAL ANALYSIS PERFORMED TO DETERMINE WHICH REPLACED PART RESOLVED THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE REMOVED ASSEMBLIES HAVE NOT BEEN FURTHER EVALUATED TO DETERMINE THE CAUSE OF THE REPORTED FAILURE. (B)(4): PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. SEVERAL THERAPY RELATED EVENT CODES WERE NOTED TO BE LOGGED IN THE DEVICE. DURING INVESTIGATION, PHYSIO-CONTROL REPLACED THE BIPHASIC AND THERAPY PCB ASSEMBLIES, THE HIGH ENERGY STORAGE CAPACITOR AND THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE THERAPY, BIPHASIC AND THE SYSTEM PCB. PHYSIO-CONTROL DETERMINED THE CAUSE OF THE FAILURE TO BE THE ISOLATION RELAY ASSEMBLY. PHYSIO-CONTROL REPLACED THE ISOLATION RELAY ASSEMBLY AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. SEVERAL THERAPY RELATED EVENT CODES WERE NOTED TO BE LOGGED IN THE DEVICE. PHYSIO-CONTROL REPLACED THE BIPHASIC AND THERAPY PCB ASSEMBLIES, THE HIGH ENERGY STORAGE CAPACITOR, THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE THERAPY, BIPHASIC AND THE SYSTEM PCB, AND THE ISOLATION RELAY ASSEMBLY. THERE WAS NO ADDITIONAL ANALYSIS PERFORMED TO DETERMINE WHICH REPLACED PART RESOLVED THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE REMOVED ASSEMBLIES HAVE NOT BEEN FURTHER EVALUATED TO DETERMINE THE CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT PROVIDE DEFIBRILLATION THERAPY BETWEEN 2 AND 50 JOULES AND WOULD ONLY PROVIDE A MONOPHASIC (INSTEAD OF BIPHASIC) BETWEEN 50 AND 300 JOULE LEVELS. THIS REPORTED FAILURE WAS NOT INVOLVED WITH ANY PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25674 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1