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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. HYPERABRIC CHAMBER CHAMBER, HYPERBARIC Back to Search Results
Model Number 3300HR-00
Event Date 05/18/2012
Event Type  Malfunction  
Event Description

No pt involvement and was not yet placed into clinical use. A performance check was done after installation of the chamber. The test indicated the compression rate was at 5 psi/min with a setting of 1 psi/min. Several attempts to recalibrate conducted without any change in compression rate. When the rate was set to 5 psi/min the pressurization rate was 5 psi/min. There was no issue with decompression (it went at the proper rate).

 
Manufacturer Narrative

Rate valve was changed and recalibrated. The chamber compressed and performed to specifications. Rate valve is enroute to mfr where it will be evaluated. Follow-up submission will be sent once the eval is completed.

 
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Brand NameHYPERABRIC CHAMBER
Type of DeviceCHAMBER, HYPERBARIC
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 east la palma ave.
anaheim , CA 92807
7145768400
MDR Report Key2625981
Report Number2020676-2012-00032
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 06/17/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/15/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number3300HR-00
Device Catalogue Number3300HR-00
Is The Reporter A Health Professional? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/08/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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