BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3070839 · Received April 22, 2013

    Report

    Report Number
    3015876-2013-00321
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE AN ELECTRICALLY OPEN HIGH ENERGY CAPACITOR. THE CAPACITOR WOULD NOT HOLD CHARGE AND THE DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING ROUTINE CHECK, IT WAS REPORTED THAT THE DEVICE HAD THE SERVICE INDICATION ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IN ADDITION, PHYSIO FOUND A CRITICAL MALFUNCTION THAT DISABLED THE DEVICE FROM DELIVERING DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173131 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1