CHAMBER, HYPERBARIC
Received Nov 28, 2012 · Event occurred Oct 24, 2012
Report 2020676-2012-00051 · MDR key 2854339
Device
Generic name
Hyperbaric Monoplace Chamber
Manufacturer
Sechrist Industries, Inc.Model number
3200RCatalog number
3200R
Product problems
- Improper Device Output
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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.
Additional 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.