MAUDE Adverse Event Report: SUMMIT TO SEA HYPERBARIC CHAMBER 31"; CHAMBER HYPERBARIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

I was sitting inside a hyperbaric chamber from summit to see and the zipper malfunctioned and the chamber popped open with me in it.

• Brand Name: HYPERBARIC CHAMBER 31"
• Type of Device: CHAMBER HYPERBARIC
• Manufacturer (Section D): SUMMIT TO SEA
• MDR Report Key: 7340835
• MDR Text Key: 102583046
• Report Number: MW5075868
• 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
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 54