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U.S. Department of Health and Human Services

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

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SUMMIT TO SEA HYPERBARIC CHAMBER 31" CHAMBER HYPERBARIC Back to Search Results
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.

 
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Brand NameHYPERBARIC CHAMBER 31"
Type of DeviceCHAMBER HYPERBARIC
Manufacturer (Section D)
SUMMIT TO SEA
MDR Report Key7340835
Report NumberMW5075868
Device Sequence Number1
Product CodeCBF
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 Received03/14/2018
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
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/14/2018 Patient Sequence Number: 1
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