BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2073115 · Received March 17, 2011

    Report

    Report Number
    3015876-2011-00250
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE QUIK-COMBO THERAPY CABLE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED QUIK-COMBO THERAPY CABLE ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE A BROKEN PIN (1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DETECT A PATIENT CONNECTION VIA THE THERAPY CABLE. THE EMS CREW RESPONDED TO A CALL AND FOUND THE PATIENT BREATHING UPON ARRIVAL. WITHIN APPROXIMATELY ONE (1) MINUTE, THE PATIENT WAS WITNESSED GOING INTO A VENTRICULAR FIBRILLATION (VF) CARDIAC ARREST. ACCORDING TO A 4-LEAD ECG ANALYSIS THRU THE ECG CABLE, THE PATIENT WAS IN A VF CARDIAC ARREST FOR LESS THAN TEN (10) SECONDS AND THEN WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA), THE CREW DID NOT RETRIEVE AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) AS THE PATIENT WAS NOT IN A SHOCKABLE RHYTHM AND DID NOT REQUIRE DEFIBRILLATION. THE PATIENT WAS PRONOUNCED DECEASED. AFTER THE EVENT, THE CUSTOMER NOTICED A PIN FROM THE QUIK-COMBO THERAPY CABLE ASSEMBLY STUCK IN THE CORRESPONDING THERAPY CONNECTOR AND REMOVED IT WITH A PAIR OF PLYERS. THE HEALTH PROFESSIONAL AT THE SCENE REPORTED THAT THE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON THE PATIENT. PHYSIO-CONTROL'S CLINICAL SPECIALIST REVIEW OF THE REPORTED EVENT ALSO DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR