BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1191363 · Received September 26, 2008

    Report

    Report Number
    3015876-2008-01377
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Removal / Correction Number
    3015876-08/27/08-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD CORRECTIVE ACTION HAS BEEN INITIATED TO CONTACT THE CUSTOMER BY TELEPHONE TO INFORM THEM OF THE REPORTED PROBLEM. A LETTER IS ALSO BEING PROVIDED TO THE CUSTOMER INSTRUCTING THEM TO EITHER REMOVE THE DEVICE FROM USE OR TO REMOVE AND DISCARD THE SHOCK BUTTON COVER UNTIL A REPLACEMENT DEVICE CAN BE PROVIDED.

    Description of Event or Problem · 1

    AN INTERNAL INVESTIGATION BY PHYSIO CONTROL FOUND THAT THIS DEVICE WAS MIS-CONFIGURED DUE TO THE INSTALLATION OF MISMATCHED HARDWARE AND SOFTWARE CONFIGURATIONS DURING A DEVICE REWORK PROCESS PRIOR TO SHIPMENT. THE DEVICE WAS FOUND TO HAVE THE 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 PT 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