VITAERIS 320
Received Apr 3, 2017 · Event occurred Mar 28, 2017
Report MW5068900 · MDR key 6459804
Device
Product problems
- Burst Container or Vessel
- Material Separation
- Noise, Audible
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
OVER THE PAST MONTH, THE INSIDE ZIPPER OF OUR OXYHEALTH VITAERIS 320 (SN (B)(4)) HAS COME APART UNDER THE NORMAL OPERATING PRESSURE OF 4LBS PRESSURE. BOTH THE TOP AND INSIDE (LOWER) ZIPPER WERE ENTIRELY ZIPPED TO THE END OF THE ZIPPERS. THE CHAMBER WAS INFLATED TO 4LBS (1.3ATA) PRESSURE FOR ABOUT TWO MINUTES AT FULL INFLATION BEFORE THERE WAS A LOUD NOISE AND THE INSIDE ZIPPER CAME APART, AND ALL AIR SUDDENLY EXHAUSTED FROM THE CHAMBER (RAPID DEFLATION). AFTER EXITING THE CHAMBER, I WAS ABLE TO SLIDE THE ZIPPER TO THE OTHER END OF THE TRACK, AND THEN IT ZIPPED UP FINE AGAIN TO THE HEAD-TOP END OF THE CHAMBER AND THE CHAMBER SEEMED TO WORK FINE. THE TOP ZIPPER WAS STILL TOTALLY ZIPPED AND NOT UNDONE AFTER THE INSIDE ZIPPER FELL APART. IT HAS DONE THIS THREE TIMES IN THE LAST MONTH. WE HAVE NOT USED THE CHAMBER SINCE THE LAST INCIDENT FOR FEAR OF INJURING PATIENTS. OXYHEALTH HAS SENT A ZIPPER REPAIR KIT AS A SOLUTION TO FIX THE ISSUE ON MY OWN.