BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER

    MDR report key: 10668229 · Received October 12, 2020

    Report

    Report Number
    2020676-2020-00016
    Event Type
    Death
    Date Received
    October 12, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 8, 2020
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    CBF
    PMA / PMN Number
    K052713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORT OF A DEATH. NO DEVICE MALFUNCTION WAS REPORTED. THE DEVICE WAS NOT RETURNED TO SECHRIST. SECHRIST CERTIFIED TECHNICIAN VISITED THE FACILITY AND EVALUATED THE DEVICE. TECHNICIAN COMPLETED CHAMBER PERFORMANCE EVALUATION ON (B)(6) 2020, AFTER PATIENT INCIDENT. CHAMBER PERFORMED PER MANUFACTURER'S ANNUAL PREVENTIVE MAINTENANCE SPECIFICATIONS AND NO ERRORS WERE NOTED. THE INSTRUCTIONS FOR USE STATE "HYPERBARIC CHAMBERS ARE DESIGNED TO ADMINISTER OXYGEN AT 100% CONCENTRATION UP TO 3.0 ATMOSPHERES ABSOLUTE (ATA) OF PRESSURE." THE IFU ALSO STATES "CONTRAINDICATIONS MUST BE CAREFULLY WEIGHED BY THE PHYSICIAN WITH EACH PATIENT'S UNIQUE PREEXISTING CONDITIONS OR CONCURRENT THERAPIES." AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    SECHRIST WAS NOTIFIED, BY A THIRD PARTY, ABOUT A SOCIAL MEDIA POST, OF A CHILD'S DEATH AT A HYPERBARIC THERAPY CLINIC, WHICH PROMPTED SECHRIST TO CONTACT THE FACILITY. SECHRIST WAS NOT INITIALLY NOTIFIED BY THE CLINIC WHEN THE INCIDENT TOOK PLACE. SECHRIST CONTACTED THE CUSTOMER WHO REPORTED THAT THEIR FACILITY TREATED AN (B)(6)-MONTH OLD CHILD WHO SUFFERED A NEAR DROWNING INCIDENT, WHICH OCCURRED IN (B)(6) 2020, AND LEFT THE CHILD IN A VEGETATIVE AND UNRESPONSIVE STATE. THE CHILD, ACCOMPANIED BY HIS FATHER INSIDE THE CHAMBER COMPLETED A 60 MINUTE HYPERBARIC TREATMENT. THIS WAS THE CHILD'S FIRST TREATMENT. AFTER THE TREATMENT, THE CHILD WAS ADMINISTERED CPR AND TAKEN TO THE EMERGENCY ROOM. THE HBO FACILITY WAS INFORMED THE CHILD PASSED OF CARDIORESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132284 SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER CHAMBER, HYPERBARIC PRODUCT CODE: CBF CBF SECHRIST INDUSTRIES, INC 3600E/ER

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Death