MONOPLACE HYPERBARIC CHAMBER

Additional Manufacturer Narrative

ATTEMPTS TO SCHEDULE ON SITE EVALUATION OF DEVICES AND OBTAIN CLARIFICATION OF MALFUNCTION REPORTED FROM WITH USER FACILITY UNSUCCESSFUL. WILL CONTINUE ATTEMPTS TO MAKE CONTACT AN WILL SUBMIT UPDATED INFORMATION WHEN RECEIVED IN F/U REPORTS.

Description of Event or Problem

MEDWATCH RECEIVED FROM FDA VIA MAIL 04/26/2010. TWO MEDWATCH FORMS SUBMITTED FOR EACH OF THE CHAMBERS INVOLVED. REFERENCE 2020676-2010-00008. THE FOLLOWING IS DIRECTLY TRANSCRIBED FROM MEDWATCH FORM. EVENT DESCRIPTION: THE TWO CHAMBERS WILL NOT EMERGENTLY DECOMPRESS TO SURFACE USING THE EMERGENCY VENT BUTTON WHEN THE OXYGEN VALVES ARE CUT OFF TO MEET THE TWO MINUTE (B)(6) REQUIREMENTS. THE CHAMBERS WILL DECOMPRESS, BUT NOT AS QUICKLY AS THEY SHOULD. BOTH CHAMBERS RETURNED FOR THE REQUIRED TEN YEAR RETROFIT IN 2007 AND 2008. HEALTH PROFESSIONAL'S IMPRESSION: THERE IS A POTENTIAL FOR HARM TO THE PT AS WELL AS THE EMPLOYEE IF THERE IS A FIRE AND THE CHAMBER DOES NOT DECOMPRESS IN A TIMELY MANNER. THE PT WAS UNDERGOING HYPOBARIC THERAPY FOR TREATMENT OF A WOUND. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSE TO DO.