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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERTEC/SUMMIT TO SEA GRAND DIVE VERTICAL 1.3 ATA PORTABLE HYPERBARIC CHAMBER

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CERTEC/SUMMIT TO SEA GRAND DIVE VERTICAL 1.3 ATA PORTABLE HYPERBARIC CHAMBER Back to Search Results
Model Number 40" GRAND DIVE
Device Problem Burst Container or Vessel (1074)
Patient Problems Pain (1994); Tinnitus (2103)
Event Date 02/26/2012
Event Type  Injury  
Event Description

A 40" portable hyperbaric chamber, brand name: grand dive vertical 1. 3 ata, purchased from healing dives inc, and manufactured by certec/summit to sea was in use at home by (b)(6). During treatment, the hyperbaric chamber exploded while two persons were inside. The occupants complained of ear ringing and pain. One of the persons was (b)(6) at that time. This was a brand new hyperbaric chamber that had been in service for only three weeks. The mfr sent a new one. One week after using the new one, the device began to fail. (b)(6) stopped using it and informed the seller. Seller claims that this is a common occurrence with that particular model and compares it with (b)(6), a work in progress. Reason for use: severe migraines. Dates of use: (b)(6) 2012.

 
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Brand NameGRAND DIVE VERTICAL 1.3 ATA
Type of DevicePORTABLE HYPERBARIC CHAMBER
Manufacturer (Section D)
CERTEC/SUMMIT TO SEA
1744 avocet lane
mound MN 55364
MDR Report Key2887363
MDR Text Key241284487
Report NumberMW5028255
Device Sequence Number1
Product Code CBF
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 12/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number40" GRAND DIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2012
Is The Reporter A Health Professional? No
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? No Answer Provided
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/15/2012 Patient Sequence Number: 1
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