SECHRIST HYPERBARIC OXYGEN CHAMBER MODEL 3300H/HR

Additional Manufacturer Narrative

THIS REPORT IS SOLELY FOR THE CUT SUSTAINED BY THE STAFF MEMBER, DURING A TRAINING SESSION, WHILE IN USE WITH THE CHAMBER. THE MIRROR GUIDANCE SYSTEM, WHICH WAS REPORTED AS HAVING SHARP EDGES, WAS MOUNTED ON THE TOP OF THE CHAMBER. THE CHAMBER DID NOT MALFUNCTION AND IS WORKING WITHIN SPECIFICATIONS. THE MIRROR GUIDANCE SYSTEM HAS BEEN REMOVED FROM THE CHAMBER AND IS NO LONGER IN USE. THE MIRROR GUIDANCE SYSTEM WAS REQUESTED TO BE RETURNED AND HAS NOT BEEN RECEIVED FOR EVALUATION. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NUMBER (B)(4).

Description of Event or Problem

THIS REPORT IS FOR AN ACCESSORY THAT WAS ATTACHED TO THE CHAMBER. THERE WAS NO DEVICE MALFUNCTION REPORTED. CUSTOMER REPORTED THE MIRROR, FOR THE MIRROR GUIDANCE SYSTEM, HAS SHARP EDGES AND A STAFF MEMBER CUT HIS HEAD ON ONE OF THE EDGES. THE STAFF MEMBER APPLIED PRESSURE TO THE CUT. THE CUT WAS WASHED AND A BAND-AID WAS PUT ON THE CUT. NO FURTHER MEDICAL INTERVENTION WAS REPORTED.