BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIO CONTROL LP-10

    MDR report key: 275774 · Received April 27, 2000

    Report

    Report Number
    275774
    Event Type
    Death
    Date Received
    April 27, 2000
    Date of Event
    April 18, 2000
    Report Date
    April 26, 2000
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMBULANCE RESPONDED TO A PULSELESS 7 MONTH OLD INFANT. ADVANCED LIFE SUPPORT WAS INITIATED. WHILE TRANSPORTING THE INFANT TO THE HOSP, PT WAS PLACED ON A CARDIAC MONITOR. THE MONITOR DISPLAYED A "V-FIB" RHYTHM. MEDIC ATTEMPTED TWO (2) SHOCKS WITH NO CHANGE IN THE INFANT'S STATUS. INFANT DIED AT THE HOSP. THE MEDIC SUSPECTED A PROBLEM WITH THE MONITOR. THE MONITOR WAS EXAMINED BACK AT THE OPERATIONS BY THE MFR'S TECH, WHO CONCLUDED THAT THE PEDIATRIC PADDLES WERE NOT FUNCTIONING DUE TO A "BENT CONNECTOR." AS A RESULT, THE UNIT DISPLAYED A SHOCK, BUT NONE WERE EVER DELIVERED. BABY'S WEIGHT IS 7-10 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL LP-10 LIFE PAK EKG MONITOR LDD PHYSIO CONTROL LP-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Death