HYPERBARIC CHAMBER

Additional Manufacturer Narrative

SUPPLEMENTAL REQUIRED FOR CORRECTION TO SECTION G5 PMA/510(K) FROM (B)(4).

Description of Event or Problem

SUPPLEMENTAL REQUIRED TO CORRECT 510(K) NUMBER.

Additional Manufacturer Narrative

SECHRIST FIELD SERVICE TECHNICIAN STRAIGHTENED OUT THE BRACKET ON THE CHAMBER THAT STOPS THE GURNEY FROM TRAVELING INTO THE PURGE HEADER AND REPAIRED THE SEVERED EMERGENCY VENT LINE AND TESTED THE EMERGENCY VENT FUNCTION OF THE CHAMBER WHICH WAS WORKING IN SPECIFICATION. HISTORICAL COMPLAINT REVIEW FOR SIMILAR DEVICES, FOUND NO SIMILAR INCIDENTS. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. 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. NOTE: THIS REPORT IS BEING MADE BASED ON THE FINDINGS THAT THE EMERGENCY VENT LINE WAS DAMAGED AND MAY NOT BE DETECTED BY THE USER DURING A PROCEDURE WITH A PATIENT. IN THE EVENT OF AN EMERGENCY THE CUSTOMER WOULD NOT BE AWARE THAT THE EMERGENCY VENT FUNCTION IS NOT WORKING PROPERLY. MANUFACTURER REFERENCE FILE (B)(4).

Description of Event or Problem

SECHRIST FIELD SERVICE TECHNICIAN WAS AT THE FACILITY PERFORMING A PREVENTATIVE MAINTENANCE ON THE CHAMBER AND FOUND THAT THE EMERGENCY VENT ON THE CHAMBER WAS SEVERED FROM THE BASE FRAME. THE TECHNICIAN FOUND THE BRACKET THAT STOPS THE GURNEY FROM TRAVELING INTO THE PURGE HEADER WAS BENT WHICH CAUSED THE DAMAGE TO THE EMERGENCY VENT LINE. NO PATIENT CONTACT OR INJURY OCCURED.