BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3180835 · Received June 20, 2013

    Report

    Report Number
    3015876-2013-00532
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL¿S CLINICAL SPECIALIST REVIEW OF THE REPORTED EVENT DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE REPORTED ISSUE WAS NOT DUPLICATED. THE EVENT DATA RECORDED BY THE DEVICE SHOWS THAT THE DEVICE POWER WAS TURNED OFF APPROXIMATELY SEVEN SECONDS AFTER DEFIBRILLATION CHARGE WAS COMPLETED. IT HAS NOT BEEN CONCLUSIVELY DETERMINED HOW THE DEVICE WAS TURNED OFF, HOWEVER, IT APPEARS LIKELY THAT THE DEVICE ON/OFF POWER SWITCH WAS INADVERTENTLY PRESSED AND CAUSED THE DEVICE TO BE TURNED OFF. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A PATIENT EVENT, IT WAS REPORTED THAT THE DEVICE CHARGED UP TO SHOCK BUT IT LOST POWER BEFORE THE SHOCK WAS ADMINISTERED TO THE PATIENT. THE PATIENT HAD A WITNESSED COLLAPSE AND CPR WAS IN PROGRESS WHEN EMT ARRIVED IN APPROXIMATELY 2-3 MINUTES FOLLOWING DISPATCH. IT WAS NOT KNOWN HOW LONG CPR WAS GIVEN TO PATIENT PRIOR TO EMT ARRIVAL. THE LOCAL SHERIFF ARRIVED JUST AS THE DEVICE LOST POWER AND CONNECTED A LIFEPAK 500 DEFIBRILLATOR WITH A DIFFERENT SET OF ELECTRODES WITHIN A MINUTE. THE PATIENT RECEIVED A DEFIBRILLATION SHOCK WITH THE SECOND DEFIBRILLATOR. THE PATIENT WAS RESUSCITATED BUT PASSED AWAY FOUR DAYS LATER AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279611 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1