BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHYSIO-CONTROL

    MDR report key: 185696 · Received September 3, 1998

    Report

    Report Number
    185696
    Event Type
    Other
    Date Received
    September 3, 1998
    Date of Event
    August 27, 1998
    Report Date
    September 1, 1998
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FAILED APNEA TEST AND WAS REPLACED ON VENTILATOR. VENTRICULAR FIBRILLATION NOTED ON CARDIAC MONITOR. CHEST COMPRESSIONS INITIATED AND PT DEFIBRILLATED AT 200 JOULES. APPROX 45 SECONDS POST DEFIBRILLATION FLASH FIRE NOTED ON LEFT SIDE OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO-CONTROL DEFIBRILLATOR LDD PHYSIO-CONTROL LIFE PAK 9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other