MONOPLACE HYPERBARIC CHAMBER
Received May 26, 2010 · Event occurred Apr 8, 2010
Report 2020676-2010-00008 · MDR key 1708037
Device
Product problems
- Device Operates Differently Than Expected
- Fail-Safe Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
ATTEMPTS TO SCHEDULE ON SITE EVAL OF DEVICES AND OBTAIN CLARIFICATION OF MALFUNCTION REPORTED FROM WITH USER FACILITY UNSUCCESSFUL. WILL CONTINUE ATTEMPTS TO MAKE CONTACT AND WILL SUBMIT UPDATED INFORMATION WHEN RECEIVED IN F/U REPORTS.
Description of Event or Problem
MEDWATCH RECEIVED FROM FDA VIA MAIL (B)(6) 2010. TWO MEDWATCH FORMS SUBMITTED FOR EACH OF THE CHAMBERS INVOLVED. REFERENCE 2020676-2010-00009. 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 TWO MINUTES NATIONAL FIRE PROTECTION ASSOCIATION (NFPA) 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 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 SUPPOSED TO DO.