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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL

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SECHRIST INDUSTRIES, INC. 3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL Back to Search Results
Model Number 3600E
Event Date 09/27/2010
Event Type  Malfunction  
Event Description

Patient's first treatment and was taught how to clear ears. Twelve minutes into treatment, going down to pressure and compressing at 1. 0psi/minute heading toward 2ata. When the chamber got to 1. 52ata, it suddenly went back up to 1. 20ata. Then it went from 1. 20ata back to 1. 52ata in 5 seconds. This appeared to cause ear pain to the pt as the pt grabbed her head. Attendant set the pressure dow to 1. 10ata to stop the chamber pressure from elevating. The new set pressure was at 1. 10ata on the dial and the pressure continued going up. It finally stopped at 1. 57ata and then started coming down at a normal rate, slowly, at 1psi/minute. The doctor checked the pt after the pt was removed from the chamber and said pt had a teeds reading of t3 on the right ear.

 
Manufacturer Narrative

Device failure related to loss of pressure at user facility. Device requires 45 to 70 psi pressure. Pressure reading at the main gauge read 40 psi.

 
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Brand Name3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL
Type of Device3600E
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 Key1889819
Report Number2020676-2010-00030
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 10/26/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3600E
Device Catalogue Number3600E
Is The Reporter A Health Professional? No
Distributor Facility Aware Date09/27/2010
Date Manufacturer Received09/27/2010
Was Device Evaluated By Manufacturer? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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