BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERBARIC CHAMBER

    MDR report key: 7853825 · Received September 6, 2018

    Report

    Report Number
    2020676-2018-00015
    Event Type
    Death
    Date Received
    September 6, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 14, 2018
    Manufacturer
    SECHRIST INDUSTRIES
    Product Code
    CBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL INSTRUCTED THAT CHAMBER BE TAKEN OUT OF SERVICE. ON (B)(6) 2018, THE HOSPITAL ASSIGNED AN INDEPENDENT TECHNICIAN (B)(6) WITH (B)(4) TO INSPECT THE CHAMBER AND THE CHAMBER WAS FOUND TO MEET SPECIFICATION. ON AUGUST 27, 2018 (B)(4) WITH SECHRIST INDUSTRIES, THE CHAMBER WAS TESTED AND PERFORMED TO MANUFACTURER SPECIFICATIONS. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED. THE CHAMBER, SERIAL NUMBER (B)(4), WAS MANUFACTURED ON 07/01/2011. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPIRED POST TREATMENT OF HBOT (HYPERBARIC OXYGEN THERAPY). PATIENT WAS RECEIVING HIS 14TH HBOT TREATMENT OF 110 MINUTES AND WAS BEING TREATED FOR A DIABETIC FOOT ULCER. TECHNICIAN OPERATING THE CHAMBER NOTICED THE PATIENT WAS UNRESPONSIVE AND WAS REMOVED FROM THE CHAMBER, WITH NO RESPIRATION POST TREATMENT AND CPR WAS INITIATED BY STAFF. AED WAS UNTILIZED WITHOUT SHOCKS BEING GIVEN. EMS RESPONDED WITHIN 5 MINUTES AND CONDUCTED A FULL CODE FOR 50 MINUTES BEFORE PATIENT WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691107 HYPERBARIC CHAMBER HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death