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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CAHMBER 32" HYPERBARIC CHAMBER 32"

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SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CAHMBER 32" HYPERBARIC CHAMBER 32" Back to Search Results
Model Number 3200
Event Date 10/18/2012
Event Type  Malfunction  
Event Description

The hyperbaric technician was compressing the chamber to 3 ata at rate of 1. 5 psi/min during a scheduled testing. When the chamber reached 2. 5 ata the technician heard a loud pop and gas escaping form the chamber. Then the chamber rapidly decompressed. The technician shut off the gas supply to the chamber. An initial observation was completed by the hyperbaric technician and reported to the manufacturer. The door handle had moved 90 degrees toward the open position. The swing arm did not move beyond the open position and held the door in place. The door gasket was blown out of place and crumpled in the limited space between the door and swing arm. Immediately after the incident the chamber was taken out of service. The chamber was evaluated and photographed by a representative of the manufacturer, who went to the customer's facility, (b)(4) 2012. During the evaluation a loaner hyperbaric chamber was installed so that this chamber could be sent back to the manufacturer and tested.

 
Manufacturer Narrative

The hyperbaric chamber was overhauled by the manufacturer in (b)(4) 2012. The device has been received by the manufacturer for evaluation. The team evaluating the device is gathering information before proceeding with the investigation. A plan of action for the evaluation is being put together before the chamber is tested and touched.

 
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Brand NameMONOPLACE HYPERBARIC CAHMBER 32"
Type of DeviceHYPERBARIC CHAMBER 32"
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 east la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key2857513
Report Number2020676-2012-00050
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 11/16/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/16/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3200
Device Catalogue Number3200
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received10/18/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/28/1995
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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