BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK AUTOMATIC EXTERNAL DEFIBRILLATOR

    MDR report key: 32146 · Received April 10, 1996

    Report

    Report Number
    32146
    Event Type
    Death
    Date Received
    April 10, 1996
    Date of Event
    March 28, 1996
    Report Date
    April 5, 1996
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED 3/27/96. PT CONDITION WORSENED OVERNIGHT. DAY OF EVENT, MD AND HUSBAND AT BEDSIDE WHEN PT BECAME BRADYCARDIC, ACLS PROTOCOL INITIATED. RHYTHM CHANGED TO V-TACH FOLLOWED BY V-FIB AT WHICH TIME PT WAS DEFIBRILLATED. BODY DID NOT JERK. ANOTHER UNIT WAS BROUGHT IN AND USED. CODE SUMMARY FROM ORIGINAL DEVICE CONFIRMED NO DEFIB HAD OCCURRED. LATER AFTER REVIEW OF THE CODE, BIOMED CHECK OF DEVICE AND INTERVIEW WITH NURSES IT WAS DETERMINED THAT THE PACER/DEFIB PADS WERE NOT PLUGGED IN TO THE UNIT INITIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK AUTOMATIC EXTERNAL DEFIBRILLATOR DEFIBRILLATOR MKJ PHYSIO-CONTROL 9P

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death