BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAERIS

    MDR report key: 5348134 · Received December 31, 2015

    Report

    Report Number
    MW5058949
    Event Type
    Injury
    Date Received
    December 31, 2015
    Date of Event
    December 29, 2015
    Report Date
    December 31, 2015
    Manufacturer
    HYPERBARIC TECHNOLOGIES INC./ OXYHEALTH
    Product Code
    CBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS TREATING A PATIENT IN A VITAERIS 320 HYPERBARIC CHAMBER. IT CAME TIME TO DEPRESSURIZE THE CHAMBER AND RIGHT AFTER SHE TURNED THE KNOB TO LET THE PRESSURE OUT, THE VITAERIS 320 HYPERBARIC CHAMBER EXPLODED CAUSING THE ZIPPER TO RIP OFF. A WHITE DUST BLEW OUT EVERYWHERE AND THE PATIENT AND NURSE WERE PRETTY SHAKEN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861904 VITAERIS PORTABLE HYPERBARIC CHAMBER CBF HYPERBARIC TECHNOLOGIES INC./ OXYHEALTH VITAERIS 320

    Patients

    Seq Age Sex Outcome Treatment
    1