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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3600E HYPERBARIC CHAMBER MONOPLACE HYPERBARIC CHAMBER MODEL 3600E

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SECHRIST INDUSTRIES, INC. 3600E HYPERBARIC CHAMBER MONOPLACE HYPERBARIC CHAMBER MODEL 3600E Back to Search Results
Model Number 3600E
Event Date 05/05/2008
Event Type  Malfunction  
Event Description

Chamber went into alarm mode immediately after turning chamber on. Alarm code e302 displayed, indicating pressure transducer issue. Hard reset done per ifus, but condition not changed. New ecm board cq 306 installed, calibrated and performance verified. Chamber restored to service.

 
Manufacturer Narrative

Facility has previous history of electrical surges which required chamber resetting. Service technician advised customer to install surge protectors. The original system board was replaced in the field. System board was investigated and could not find any issues with the board.

 
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Brand Name3600E HYPERBARIC CHAMBER
Type of DeviceMONOPLACE HYPERBARIC CHAMBER MODEL 3600E
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 e. la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key1785630
Report Number2020676-2010-00016
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 08/02/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number3600E
Device Catalogue Number3600E
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2010
Event Location Hospital
Date Manufacturer Received05/09/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/29/2008
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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