BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITAERES 320

    MDR report key: 3838678 · Received May 21, 2014

    Report

    Report Number
    2438426-2014-00001
    Event Type
    Death
    Date Received
    May 21, 2014
    Manufacturer
    HYPERBARIC TECHNOLOGIES, INC.
    Product Code
    CBF
    PMA / PMN Number
    K001409
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE SAMPLES OF THE AIR HOSE CONNECTOR (P/N HFC 17612 BY COLDER PRODUCTS CO) (IDENTICAL TO THE PART ON #3398) WERE RANDOMLY SELECTED FROM INVENTORY AND PERFORMANCE TESTING WAS CONDUCTED AND ALL FIVE FOUND TO BE PER SPECIFICATIONS. THE AIR HOSE WAS ATTACHED TO A VITAERES 320 HYPERBARIC CHAMBER AND TESTS WERE CONDUCTED TO MAKE THE CONNECTOR FAIL BUT THE CONNECTOR REMAINED INTACT. THE ONLY WAY TO MAKE IT DISCONNECT OTHER THAN BY HAND WAS TO HAVE A STATIONARY BLUNT OBJECT NEXT TO THE EXACT CENTER OF THE PUSH BUTTON RELEASE AND AFTER 3.5 POUNDS OF PRESSURE, IT DISCONNECTED. WE HAVE CONCLUDED THAT GIVEN THE PERFECT SAFETY RECORD OF OVER 13 YEAR AND (B)(4) CHAMBERS USING THIS DEVICE, AND THE EXTREME UNLIKELIHOOD OF THIS EVER TO HAPPEN AGAIN WE FEEL MOST CONFIDENT IN ITS USE. THE IFUS OF THIS PRODUCT RECOMMEND THAT USE OF THE DEVICE INCLUDE SUPERVISION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303037 VITAERES 320 73CBF CBF HYPERBARIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1