VITAERES 320
Received May 21, 2014
Report 2438426-2014-00001 · MDR key 3838678
Device
Generic name
73cbf
Manufacturer
Hyperbaric Technologies, Inc.Product problems
- Disconnection
- Device Dislodged or Dislocated
Patient
Not reported
- Death
- Suffocation
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
FIVE SAMPLES OF THE AIR HOSE CONNECTOR (P/N HFC 17612 BY COLDER PRODUCTS CO) (IDENTICAL TO THE PART ON #3398) WERE RANDOMLY SELECTED FROM INVENTORY AND PERFORMANCE TESTING WAS CONDUCTED AND ALL FIVE FOUND TO BE PER SPECIFICATIONS. THE AIR HOSE WAS ATTACHED TO A VITAERES 320 HYPERBARIC CHAMBER AND TESTS WERE CONDUCTED TO MAKE THE CONNECTOR FAIL BUT THE CONNECTOR REMAINED INTACT. THE ONLY WAY TO MAKE IT DISCONNECT OTHER THAN BY HAND WAS TO HAVE A STATIONARY BLUNT OBJECT NEXT TO THE EXACT CENTER OF THE PUSH BUTTON RELEASE AND AFTER 3.5 POUNDS OF PRESSURE, IT DISCONNECTED. WE HAVE CONCLUDED THAT GIVEN THE PERFECT SAFETY RECORD OF OVER 13 YEAR AND (B)(4) CHAMBERS USING THIS DEVICE, AND THE EXTREME UNLIKELIHOOD OF THIS EVER TO HAPPEN AGAIN WE FEEL MOST CONFIDENT IN ITS USE. THE IFUS OF THIS PRODUCT RECOMMEND THAT USE OF THE DEVICE INCLUDE SUPERVISION.