MAUDE Adverse Event Report: HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/04/2022

Event Type  Injury  

Event Description

Mother-in-law had a session in the chamber and a few hours later was admitted to the hospital with dx.Tia.Not saying the chamber caused the tia but could make it worse.You can not dive with a recent tia but this guy is more than happy to invite her back and help "cure " her and everyone else of a myriad of diseases.(b)(6).Please be aware this hyperbaric chamber is not a hyperbaric oxygen chamber as found in hospitals.The guy who administers this is a minister who is making unfounded claims about his chamber which, again, is not a hyperbaric oxygen chamber as noted on his website.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• MDR Report Key: 13887762
• MDR Text Key: 288024166
• Report Number: MW5108492
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White