CHAMBER, HYPERBARIC
Received Jul 3, 2014 · Event occurred May 23, 2014
Report 2020676-2014-00025 · MDR key 3983290
Device
Generic name
Hyperbaric Monoplace Chamber
Manufacturer
Sechrist Industries, Inc.Model number
3300HCatalog number
3300H-01-1
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING CLINICAL USE THE CHAMBER DECOMPRESSED FROM 2.0 AT TO 0 ATA IN 6.5 MINUTES. TESTING OF THE CHAMBER WAS DONE, BY THE CENTER STAFF, AFTER THE PT WAS REMOVED AND THE FAILURE WAS DUPLICATED. INFO PROVIDED BY THE CENTER STATES THAT THE PT WAS NOT INJURED. THEY ARE REPORTED AS DOING "FINE".
Additional Manufacturer Narrative
THE REPORTED COMPLAINT THAT THE CHAMBER IS DECOMPRESSING FASTER THAN SPEC WAS VERIFIED. THE DECOMPRESSION TIMING FROM 2.0 ATA TO 0 ATA IN 6.5 MINUTES COULD BE A POTENTIAL SAFETY ISSUE IF THE PT HAS LUNG DISEASE AND HOLDS THEIR BREATH. THIS COULD RESULT IN GAS BECOMING TRAPPED IN THEIR CHEST. THE CHAMBER WAS EVALUATED BY A TECHNICIAN FROM THE MFR. HE FOUND THAT THE RATE VALVE WS OUT OF CALIBRATION AND REQUIRED AN ADJUSTMENT. A NOTE WAS INCLUDED IN THE REPORT STATING THAT THE ISSUE WAS RESOLVED. THE CAUSE OF THE RATE VALVE GOING OUT OF SPEC AND INCREASING THE DECOMPRESSION TIMING IS UNK. THE PROBABLE CAUSE IS DRIFT.