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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER 3200

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SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER 3200 Back to Search Results
Model Number 3200
Event Date 04/08/2010
Event Type  Malfunction  
Event Description

Medwatch received from fda via mail (b)(6) 2010. Two medwatch forms submitted for each of the chambers involved. Reference 2020676-2010-00009. The following is directly transcribed from medwatch form. Event description: the two chambers will not emergently decompress to surface using the emergency vent button when the oxygen valves are cut off to meet two minutes national fire protection association (nfpa) requirements. The chambers will decompress but not as quickly as they should. Both chambers returned for the required ten year retrofit in 2007 and 2008. Health professional's impression there is a potential for harm to the pt as the employee if there is a fire and the chamber does not decompress in a timely manner. The pt was undergoing hypobaric therapy for treatment of a wound. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

 
Manufacturer Narrative

Attempts to schedule on site eval of devices and obtain clarification of malfunction reported from with user facility unsuccessful. Will continue attempts to make contact and will submit updated information when received in f/u reports.

 
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Brand NameMONOPLACE HYPERBARIC CHAMBER
Type of Device3200
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 Key1708037
Report Number2020676-2010-00008
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 05/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number3200
Device Catalogue Number3200
Distributor Facility Aware Date05/25/2010
Date Manufacturer Received04/26/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/1997
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/26/2010 Patient Sequence Number: 1
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