CHAMBER, HYPERBARIC
Received Jun 11, 2014 · Event occurred May 12, 2014
Report 2020676-2014-00019 · MDR key 3987508
Device
Generic name
Hyperbaric Monoplace Chamber
Manufacturer
Sechrist Industries, Inc.Model number
3300HRCatalog number
3300HR-01-1
Product problems
- Output Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE REPORTED COMPLAINT THAT THE CHAMBER IS COMPRESSING SLOWER THAN SPECIFICATION AND DECOMPRESSING FASTER THAN SPECIFICATION WAS VERIFIED. THE CHAMBER WAS NOTED AS COMPRESSING FROM 5 - 6 PSI IN 86 SECONDS, 14 - 15 PSI IN 85 SECONDS AND FROM 25 -26 PSI IN 95 SECONDS. DECOMPRESSION TIMING WAS RECORDED FROM 6 -5 PSI IN 35 SECONDS. SPECIFICATION AT A RATE OF 1 PSI FOR COMPRESSION OR DECOMPRESSION IS 50 - 70 SECONDS. SLOW COMPRESSION AND/OR DECOMPRESSION PROVIDES THE PATIENT WITH ADDITIONAL TIME TO ACCLIMATE TO THE PRESSURE AND IS NOT REPORTABLE. THE DECOMPRESSION TIMING OF 35 SECONDS COULD RESULT IN BAROTRAUMA WHICH MAKES THIS REPORTED FAILURE REPORTABLE. THE CHAMBER WAS EVALUATED BY A TECHNICIAN FROM THE MANUFACTURER. HE FOUND THAT THE RATE VALVE WAS OUT OF CALIBRATION AND REQUIRED AN ADJUSTMENT. UPON ADJUSTING THE RATE VALVE THE TIMING OF THE CHAMBER WAS TESTED AND VERIFIED AS BEING WITHIN SPECIFICATION. THE CAUSE OF THE RATE VALVE GOING OUT OF SPECIFICATION AND INCREASING THE DECOMPRESSION TIMING IS UNKNOWN. THE PROBABLE CAUSE IS DRIFT.
Description of Event or Problem
DURING REGULARLY SCHEDULED TESTING THE DECOMPRESSION TIME OF THE HYPERBARIC CHAMBER WAS FOUND TO BE 35 SECONDS FROM 6 PSI TO 5 PSI. THIS IS FASTER THAN THE SPECIFICATION OF 50 - 70 SECONDS.