SECHRIST MONOPLACE HYPERBARIC CHAMBER-MODEL 3300H/HR

Description of Event or Problem

AS REPORTED BY THE USER, THE CHAMBER WAS COMPRESSING TO TREATMENT PRESSURE OF 2.5 ATA. THE CHAMBER'S SET PRESSURE GAUGE BEGAN TO DECOMPRESS QUICKLY AND STEADLILY TO ZERO. WITHIN A MINUTE OF THIS, A LOUD BOOM WAS HEARD, THE DOOR BLEW SLIGHTLY, SLIGHTLY OPENING THE SWING ARM AND DISPLACING THE LOCKING PIN. TREATMENT WAS ABORTED AND PATIENT REMOVED SAFELY. PATIENT REPORTED NO INJURIES.

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT THE CHAMBER DOOR BLEW OPEN WHILE COMPRESSING TO TREATMENT PRESSURE. PATIENT WAS INSIDE CHAMBER DURING INCIDENT BUT NO INJURIES REPORTED. CHAMBER WAS EVALUATED BY SECHRIST TRAINED TECHNICIAN AND FOUND MULTIPLE DAMAGED COMPONENTS CONSISTENT WITH A SUDDEN PRESSURE LOSS, LIKELY FROM NOT CLOSING THE DOOR ALL THE WAY. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 NO.: (B)(4).