BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC CHAMBER 31"

    MDR report key: 7340835 · Received March 14, 2018

    Report

    Report Number
    MW5075868
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 13, 2018
    Manufacturer
    SUMMIT TO SEA
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS SITTING INSIDE A HYPERBARIC CHAMBER FROM SUMMIT TO SEE AND THE ZIPPER MALFUNCTIONED AND THE CHAMBER POPPED OPEN WITH ME IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180721 HYPERBARIC CHAMBER 31" CHAMBER HYPERBARIC CBF SUMMIT TO SEA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other