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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. CHAMBER, HYPERBARIC HYPERBARIC MONOPLACE CHAMBER Back to Search Results
Model Number 3600E
Event Date 05/04/2012
Event Type  Malfunction  
Event Description

Customer reports ground resistance of chamber during clinical use was above the specification. Customer measured the ground resistance after the treatment and found the ground resistance within specification.

 
Manufacturer Narrative

On site investigation found the increased grounding was due to chamber power supply. Power supply is in route to chamber manufacturer for investigation. Customer reports the chamber is properly grounded per the manufacturer's grounding point described in the operator's manual. The manufacturer requires the chamber be properly grounded from the chamber ground connection to the hospital wall stud. With this ground installed customer reports the ground resistance is within specification. Follow-up submission will be provided on the results of the power supply investigation once they are available.

 
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Brand NameCHAMBER, HYPERBARIC
Type of DeviceHYPERBARIC MONOPLACE CHAMBER
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 w. la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 e. la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key2600711
Report Number2020676-2012-00030
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 06/01/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2012
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 Device Evaluated By Manufacturer? No
Date Device Manufactured11/29/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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