BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2061382 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00255
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    November 10, 2011
    Report Date
    February 21, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE MAIN HIGH ENERGY CAPACITOR INHIBITS THE ENERGY CHARGE AND WOULD NOT ALLOW THE DEVICE TO DELIVER A DEFIBRILLATION SHOCK. PHYSIO FURTHER EVALUATED THE MAIN HIGH ENERGY CAPACITOR AND DETERMINED THAT SOCKET 2 OF A PLUG CONNECTOR, DESIGNATOR P502 IS OPEN AND BURNED. THE CONNECTOR WAS MAKING ONLY INTERMITTENT CONTACT TO PIN 1 OF P502 AND WAS ARCING. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE ONLY HAD ITS SERVICE WRENCH ILLUMINATED, BUT STILL FUNCTIONED; HOWEVER AFTER INITIAL EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD STATE "MOTION DETECTED" WHEN CHARGING FOR A DEFIBRILLATION SHOCK AND WOULD NOT DELIVER THE SHOCK. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA