BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK DEFIBRILLATOR

    MDR report key: 35914 · Received August 23, 1996

    Report

    Report Number
    MW1009808
    Event Type
    Malfunction
    Date Received
    August 23, 1996
    Date of Event
    August 10, 1996
    Report Date
    August 21, 1996
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DROVE HIMSELF TO HOSP. PHYSICIAN EXAMINED PT AND DIAGNOSED PACEMAKER MALFUNCTION. PACEMAKER TURNED OFF. PT SHOWED TACHYCARDIA ON MONITOR. DECISION MADE TO CARDIOVERT. STAFF BROUGHT DEFIBRILLATOR TO BEDSIDE, INSERTED PLUGS INTO MACHINE AND CHECKED UNIT. UNIT CHARGED WHEN STAFF ATTEMPTED TO DISCHARGE UNIT FOR CARDIOVERSION. UNIT FAILED TO DISCHARGE PROPERLY. SEVERAL ATTEMPTS WERE MADE TO NO AVAIL. A DIFFERENT UNIT WAS OBTAINED AND CARDIOVERSION WAS SUCCESSFUL. PT EXPERIENCED NO ADVERSE EFFECTS. CHECK OF UNIT REVEALED THAT THE QUICK COMBINATION MODULE LEVER WAS NOT COMPLETELY INTO THE LOCKED POSITION. THEIR IS NO NOTATION IN THE EQUIPMENT LABEL WHICH INDICATES THE SIGNIFICANT ROLE PLAYED IN OVERALL OPERATIONS BY THIS SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK DEFIBRILLATOR DEFIBRILLATOR MONITOR PACEMAKER LDD PHYSIO CONTROL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR