BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIO-CONTROL

    MDR report key: 237546 · Received August 11, 1999

    Report

    Report Number
    237546
    Event Type
    Malfunction
    Date Received
    August 11, 1999
    Date of Event
    July 17, 1999
    Report Date
    July 29, 1999
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    PT PULSELESS, UNRESPONSIVE TO ALL STIMULI PT CYANOTIC QUICK COMBO PADS. APPLIED REVEALING V-FIB IN PADDLES MODE ON SCREEN OF LP-IV V-FIB DEFIBRILLATED AT 200 JOULES. MONITOR LATER PRINTED OUT ARTIFACT ON MONITOR STRIP CAUSING V-FIB TO BE COVERED WITH ARTIFACT UNABLE TO DOCUMENT V-FIB ACCURATELY. IT APPEARS THE MONITOR-DEFIBRILLATOR SHOULD APPROPRIATELY, BUT DID NOT MONITOR THROUGH THE "PADDLES MODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO-CONTROL LP-11 LDD PHYSIO-CONTROL LIFE PAR 11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other