SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER

Additional Manufacturer Narrative

EVALUATION OF THE CHAMBER HAS NOT BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ONCE THE EVALUATION OF THE CHAMBER HAS BEEN COMPLETED. COMPLAINT REVIEW FOR PAST TWELVE MONTHS 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. MANUFACTURER REFERENCES INCIDENT (B)(4).

Description of Event or Problem

DURING WEEKLY PRESSURE TEST AT 30 PSI OR 3 ATA THE HBO TECH RUNNING THE CHAMBER HEARD A LOUD HISSING NOISE COMING FROM THE CHAMBER DOOR REGION AND OBSERVED THAT THE CHAMBER PRESSURE STARTED TO DECREASE RAPIDLY FOLLOWED BY A LOUD POP AND TOTAL LOSS OF CHAMBER PRESSURE RESULTING IN THE DOOR HANDLE MOVING FROM 90 DEGREES TO APPROXIMATELY 30 DEGREES WHILE HOLDING THE DOOR CLOSED DURING THE TOTAL LOSS OF CHAMBER PRESSURE, ALONG WITH WHAT APPEARS TO BE A BROKEN BOLT COMING FROM THE CAM LOCK PROTECTIVE COVER. THE FOLLOWING INCIDENT DID NOT RESULT IN ANY INJURIES TO PATIENTS OR BY STANDARDS.

Description of Event or Problem

SUPPLEMENTAL MEDWATCH REQUIRED FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

INVESTIGATION OF THE RETURNED CHAMBER FOUND THE STOP PIN AND GROOVE IN SWING ARM HAVE BEEN DAMAGED, NOT ALLOWING THE CAM SHAFT TO ROTATE TO THE CLOSED POSITION IN THE DOOR. ALSO, OBSERVERED THERE IS DAMAGE TO THE TIP OF THE 3-WAY VALVE AND DAMAGE TO THE PAINT AS A RESULT OF AN INCORRECTLY ADJUSTED ADJUSTMENT STEM. NOTE: USER'S MANUAL PROVIDES ADEQUATE INSTRUCTIONS FOR PROPERLY CLOSING AND LOCKING OF THE CHAMBER DOOR. MANUFACTURER REFERENCES COMPLAINT # (B)(4).