MONOPLACE HYPERBARIC OXYGEN
Received Jan 29, 2016 · Event occurred Dec 23, 2015
Report 2020676-2016-00002 · MDR key 5409797
Device
Generic name
Hyperbaric Chamber
Manufacturer
Sechrist Industries, Inc.Model number
21762Catalog number
21762
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
REPORTED EVENT IS STILL PENDING EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING (HBOT) A ROUTINE HYPERBARIC OXYGEN THERAPY PATIENT TURNED ON HER SIDE WHILE IN THE CHAMBER AND THE BACKREST COLLAPSED TO FLAT POSITION. PATIENT STATED THAT SHE WAS NOT HURT AND CHOSE TO CONTINUE THERAPY. REPORTEDLY AT THE END OF THE THERAPY PATIENT STATED SHARP MID BACK AND SHOULDER PAIN. PATIENT WAS TREATED IN THE DEPARTMENT AND SUBSEQUENTLY TRANSFERRED TO ER FOR REVIEW.