BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 3200R HYPERBARIC CHAMBER

    MDR report key: 1625920 · Received March 8, 2010

    Report

    Report Number
    2020676-2010-00001
    Event Type
    Death
    Date Received
    March 8, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 4, 2010
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LETTER RECEIVED FROM HOSPITAL ALONG WITH MEDWATCH FORM INDICATES "... WE DON'T BELIEVE THERE IS ANY PROBLEM WITH THE CHAMBER ... STAFF HAS ALREADY CONTACTED YOU FOR A SERVICE CALL." SERVICE TECHNICIAN SENT TO HOSPITAL TO PERFORM VISUAL INSPECTION AND PERFORMANCE VERIFICATION TO APPROVED FIELD SERVICE PROCEDURE. NO ADJUSTMENTS OR REPAIRS WERE NECESSARY - DEVICE OPERATING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PROVIDED DESCRIPTION OF EVENTS TRANSCRIBED FROM LETTER SENT WITH MEDWATCH FORM. "THE PT HAD A HISTORY OF DIABETES MELLITUS, PERIPHERAL ARTERY DISEASE, LEFT BELOW KNEE AMPUTATION, OSTEOMYELITIS OF THE RIGHT FOOT AND STATUS POST RIGHT METATARSAL AMPUTATION. HE'D HAD NUMEROUS TREATMENTS BEFORE THIS DATE. DURING THIS PARTICULAR TREATMENT, HE DEVELOPED A GRAND-MAL SEIZURE THAT WAS SHORT AND PT WAS POST-ICTAL WHEN HE BEGAN TO HAVE AGONAL RESPIRATIONS. OF COURSE, DECOMPRESSION HAD ALREADY BEGUN, BUT HE WAS EMERGENTLY DECOMPRESSED WITH THIS CHANGE. TWO PHYSICIANS WERE IN ATTENDANCE AND CPR WAS ADMINISTERED SUCCESSFULLY WITH ACLS PROTOCOL. THE FOLLOWING DAY, THE PT'S TROPONIN I LEVEL ROSE TO 18.66, HIS EJECTION FRACTION WAS 16% AND HE WAS DIAGNOSED WITH ACUTE ANOXIC ENCEPHALOPATHY. HE DIED ON (B) (6) 2010."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 3200R HYPERBARIC CHAMBER HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES, INC. 3200R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death