BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 2111078 · Received May 18, 2011

    Report

    Report Number
    3015876-2011-00401
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED ON A HEAVY-SET MALE PT IN CARDIAC ARREST. CPR WAS INITIATED AND THE DEVICE WAS CONNECTED TO THE PT. THE DEVICE WOULD BEGIN ANALYZING, BUT WOULD THEN PROMPT "MOTION" AND "CONNECT ELECTRODES." THE BLS CREW WAS NEVER ABLE TO OBTAIN A COMPLETE ANALYSIS OF THE PT. THE ALS CREW ARRIVED ON THE SCENE AND CONTINUED PT CARE WITH A SECOND DEVICE (UNK TYPE OR BRAND). A SECOND SET OF DEFIBRILLATION PADS WAS CONNECTED TO THE PT. NO DEFIBRILLATION SHOCKS WERE DELIVERED TO THE PT WITH THE SECOND DEVICE. THE PT WAS DELIVERED TO THE HOSPITAL ALIVE; HOWEVER DIED LATER THAT DAY DUE TO AN ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK