BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1172066 · Received September 18, 2008

    Report

    Report Number
    3015876-2008-01156
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO CONTROL EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THE DEVICE WAS FOUND TO HAVE THE CORRECT HARDWARE FOR A FULLY AUTOMATIC DEFIBRILLATOR (NO "SHOCK" BUTTON), HOWEVER, THE DEVICE SOFTWARE WAS CONFIGURED FOR SEMI-AUTOMATIC OPERATION ("SHOCK" BUTTON REQUIRED). THE INCORRECT SOFTWARE CONFIGURATION WAS DETERMINED TO BE DUE TO A MANUFACTURING PROCESS ERROR. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    AT THE REQUEST OF THE CUSTOMER, PHYSIO CONTROL CHECKED THAT THE DEVICE WAS CONFIGURED PROPERLY AS A FULLY AUTOMATIC DEFIBRILLATOR. THE DEVICE WAS FOUND TO HAVE THE CORRECT HARDWARE FOR A FULLY AUTOMATIC DEFIBRILLATOR (NO "SHOCK" BUTTON), HOWEVER THE DEVICE SOFTWARE WAS CONFIGURED FOR SEMI-AUTOMATIC OPERATION ("SHOCK" BUTTON REQUIRED). THIS INCORRECT CONFIGURATION COULD CAUSE A SHOCK TO NOT BE DELIVERED TO A PATIENT IF NEEDED WHEN TREATING A CARDIAC ARREST.

    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 NA