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U.S. Department of Health and Human Services

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

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

Medwatch received from fda via mail 04/26/2010. Two medwatch forms submitted for each of the chambers involved. Reference 2020676-2010-00008. 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 the two minute (b)(6) 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 well 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 suppose to do.

 
Manufacturer Narrative

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

 
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Brand NameMONOPLACE HYPERBARIC CHAMBER
Type of Device3200R
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 Key1711204
Report Number2020676-2010-00009
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type Unknown
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/26/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/20/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number3200R
Device Catalogue Number3200R
Distributor Facility Aware Date05/25/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/09/1997
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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