BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1983196 · Received February 2, 2011

    Report

    Report Number
    3015876-2011-00092
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 3, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A PATIENT USE, IT WAS REPORTED THAT THE DEVICE FAILED TO ADVANCE PAST THE INITIAL VOICE PROMPTS. THE DEVICE WAS CONNECTED TO A NON-RESPONSIVE PATIENT OF UNKNOWN DOWNTIME AND REPORTED TO ONLY GIVE THE "OPEN SHIRT" AND "PLACE ELECTRODES ON PATIENT" MESSAGES AFTER PLACING THE UNEXPIRED ELECTRODES. THE DEVICE USERS CHECKED THE CONNECTIONS BUT THE ISSUE PERSISTED. THE LOCAL EMS ARRIVED ON THE SCENE AND USED A DIFFERENT SET OF ELECTRODES AND DEFIBRILLATOR TO PROVIDE THE PATIENT CARE. THE PATIENT WAS PRONOUNCED DECEASED FOLLOWING RESUSCITATION ATTEMPTS AT THE SCENE. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THERE WAS NOT SUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE IMPACT OF THE DEVICE USE. THE PROLONGED DOWNTIME CAN RESULT IN HIGH IMPEDANCE MEASUREMENTS AND THE PATIENT MAY NOT BE RECOGNIZED. FURTHERMORE, THE SECOND DEVICE (BRAND UNKNOWN) MAY HAVE HAD A RHYTHM DISPLAYED IF THE IT HAD A HIGHER THRESHOLD. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK