BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERRY HYPERBARIC CHAMBER

    MDR report key: 399680 · Received June 12, 2002

    Report

    Report Number
    1036464-2002-00001
    Event Type
    Death
    Date Received
    June 12, 2002
    Date of Event
    June 4, 2002
    Report Date
    June 6, 2002
    Manufacturer
    PERRY BAROMEDICAL CORP.
    Product Code
    CBF
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENTHOUGH THE CHAMBER WAS NOT PRESSURIZED AND IN OPERATION AND THE DOCTOR DOES NOT FEEL THE INCIDENT IS RELATED TO THE COMPANY'S DEVICE, THE COMPANY FEELS IT IS APPROPRIATE TO FILE THIS REPORT AS REPORTED TO THE COMPANY: CAR ACCIDENT PATIENT WAS DIRECTLY TRANSFERRED FROM THE EMERGENCY ROOM TO THE HYPERBARIC CHAMBER ROOM. PATIENT WAS ON ENDOTRACHEAL TUBE. A DOCTOR CONNECTED THE O2 GAS SUPPLY FROM THE CHAMBER WITH A FLOW RATE OF 30 1PM, TO EXHAUST CONNECTOR OF THE AMBU (MANUAL RESUSCITATOR). "WITHIN A FEW SECONDS THE PATIENT'S LUNG EXPLODED AND THE ENDOTRACHEAL TUBE BROKE." WHEN THIS INCIDENT OCCURRED THE CHAMBER DOOR WAS NOT CLOSED AND NO CHAMBER PRESSURE WAS USED. DOCTOR WAS PRESENT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERRY HYPERBARIC CHAMBER HYPERBARIC CHAMBER CBF PERRY BAROMEDICAL CORP. SIGMA II-4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death