BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3100765 · Received May 8, 2013

    Report

    Report Number
    3015876-2013-00371
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE DUPLICATE THE REPORTED INTERMITTENT PROBLEM. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE INTERMITTENTLY FAILED TO PASS THE USER TEST WITH HARD PADDLES AND GAVE THE "CONNECT TO TEST PLUG" MESSAGE. THE BIOMED REPORTED THAT THE PADDLES WERE FIRMLY SEATED IN THE PADDLE WELLS AND MAKING GOOD CONTACT WITH THE SHORTING BLOCK. THE BIOMED TESTED THE DEVICE WITH MULTIPLE PADDLES BUT THE PROBLEM REMAINED. THE DEVICE COULD POSSIBLY BE FAILING TO DETECT THE PADDLES CONNECTION INTERMITTENTLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201941 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1