• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SECHRIST INDUSTRIES, INC. CHAMBER, HYPERBARIC HYPERBARIC MONOPLACE CHAMBER Back to Search Results
Model Number 3200R
Event Date 10/24/2012
Event Type  Malfunction  
Event Description

During scheduled testing the tech noted that the chamber is compressing outside of mfr specifications. Set at a rate of 1, the chamber is compressing at 1 psi per 43 seconds. This rate is faster than the specified rate.

 
Manufacturer Narrative

The chamber had previously received its annual service maintenance on (b)(4) 2012. No issues regarding the functionality were noted on the report. Evaluation of the chamber verified the reported failure. At a rate of 1 the chamber was compressing 1psi per 44 seconds. The rate valve was replaced and the chamber was performance verified. It was found to function per factory specification. A request for the original rate valve has been made. An update will be sent upon eval of the rate valve.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCHAMBER, HYPERBARIC
Type of DeviceHYPERBARIC MONOPLACE CHAMBER
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
7145798400
MDR Report Key2854339
Report Number2020676-2012-00051
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 11/28/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/28/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3200R
Device Catalogue Number3200R
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/29/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/22/2004
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-