BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2800534 · Received October 22, 2012

    Report

    Report Number
    3015876-2012-00785
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED PROBLEM AFTER EXTENSIVE DEVICE TESTING. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO EVALUATED THE DEVICE EVENT RECORD IMPEDANCE LOG AND FOUND THAT THERE WAS NO ELECTRICAL CONNECTION TO THE PATIENT AT ANY TIME. THE CAUSE FOR THE CONNECT ELECTRODES MESSAGE WAS DUE TO A LACK OF ELECTRICAL CONNECTION BETWEEN THE PATIENT AND THE DEVICE. HOWEVER, A CONCLUSIVE CAUSE FOR THE EVENT WAS NOT DETERMINED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DETECT THE PATIENT CONNECTION AND KEPT ALARMING THE OPERATOR TO PLACE THE ELECTRODES ON THE PATIENT. THE PATIENT WAS FOUND COLLAPSED ON A TRAIN AND THE DEFIBRILLATOR WAS RETRIEVED TO THE SCENE WITHIN FIVE MINUTES. THE FIRST RESPONDERS THAT ARRIVED AT THE SCENE IMMEDIATELY STARTED CPR ON THE PATIENT. THE PATIENT WAS NOT RESUSCITATED. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED. PHYSIO-CONTROL'S CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THERE IS INSUFFICIENT DATA AVAILABLE TO DETERMINE THE IMPACT OF THE DEVICE USE ON THE PATIENT OUTCOME. THE PATIENT'S ECG RHYTHM IS UNKNOWN AND THE CONNECT ELECTRODES MESSAGE CAN OCCUR DUE TO VARIOUS CIRCUMSTANCES SUCH AS PROLONGED DOWNTIME THAT COULD RESULT IN AN OUT OF RANGE PATIENT IMPEDANCE; INADEQUATE SKIN PREPARATION OR DRIED ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR