BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERBARIC CHAMBER 40"

    MDR report key: 13258009 · Received January 13, 2022

    Report

    Report Number
    MW5106669
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    June 27, 2021
    Report Date
    January 12, 2022
    Manufacturer
    SUMMIT TO SEA
    Product Code
    CBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MIGRAINES, AFFECTED MEMORY; HAD A SUMMIT TO THE SEA 40" HYPERBARIC CHAMBER BY (B)(4). RENTED IT TO SEE IF IT WOULD WORK, THEN 2-3 MONTHS LATER THE ZIPPER COMPLETELY FAILED INSTANTLY DEPRESSURIZING CAUSING PHYSICAL AND MENTAL DISCOMFORT STILL ONGOING. THEN WAS CHARGED TO SHIP IT TO GET FIXED AND RETURN TO (B)(4) IN (B)(6). CONSIDERING THE TUBE WAS LESS THAN A YEAR OLD WHEN IT ARRIVED THE TUBE HAD A LARGE GASH IN THE SIDE AFTER REMOVING FROM SHIPPING BOX AND WAS ASKED TO REPAIR AT MY EXPENSE. ALSO, OXYGEN CONCENTRATOR COVERED IN DUST AND VERY DIRTY, THE SAME AS THE INSIDE OF THE TUBE AFTER SETTING UP. IT WAS NOT CLEANED AT ALL, WE WERE SENT BROKEN CIRCUIT ALARMS AND ENDED UP HAVING TO BUY A CIRCUIT ALARM OFF (B)(6) DUE TO POOR CUSTOMER SERVICE. PAID A (B)(6) DEPOSIT THAT THEY REFUSE TO RETURN TO ME. ALL IN ALL I'VE BEEN LIED TO FROM THE VERY BEGINNING AND FEEL COMPLETELY TAKEN ADVANTAGE OF BY (B)(6), WE ENDED UP GOING WITH A DIFFERENT HYPERBARIC COMPANY THAT IS MUCH MORE REPUTABLE AND NOT A SINGLE FAILURE REPORT, IT IS ALSO MUCH BETTER MADE WITH HIGHER QUALITY PARTS THAN (B)(4). AFTER SPEAKING DIRECTLY WITH (B)(4) THEY AGREED, IT WAS NOT RIGHT FOR US HAVING TO PAY THE RETURN SHIPPING BUT, HOWEVER THE CUSTOMER SERVICE SOLUTION SEEMS TO GETTING DRAGGED ON AND ON AND HAVE BEEN TRYING TO GET MY DEPOSIT BACK SINCE NOVEMBER. THIS IS AN EXTREMELY DANGEROUS PRODUCT THIS PARTICULAR RESELLER IS RENTING OUT TO THE GENERAL PUBLIC. I CAN UPLOAD A VIDEO UPON REQUEST OF THE ZIPPER FAILING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858621 HYPERBARIC CHAMBER 40" CHAMBER, HYPERBARIC CBF SUMMIT TO SEA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Other ALBUTEROL RESCUE INHALER| CALCIUM| VITAMIN C| ZINC