MAUDE Adverse Event Report: SUMMIT TO SEA HYPERBARIC CHAMBER 40"; CHAMBER, HYPERBARIC

Health Effect - Clinical Codes	Headache (1880); Memory Loss/Impairment (1958); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	06/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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).

• Brand Name: HYPERBARIC CHAMBER 40"
• Common Device Name: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SUMMIT TO SEA
• MDR Report Key: 13258009
• Report Number: MW5106669
• Device Sequence Number: 15918791
• Product Code: CBF
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL RESCUE INHALER; CALCIUM; VITAMIN C; ZINC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White