PAHI HBO CHAMBER
Received Apr 18, 2011 · Event occurred Dec 1, 2010
Report 2075477 · MDR key 2075477
Device
Generic name
Hyperbaric Oxygen Chamber
Manufacturer
Pan-america Hyperbarics IncModel number
*Catalog number
*
Lot number
*
Product problems
- Decrease in Pressure
- Device Dislodged or Dislocated
Patient
65 YR
- Pain
- Dizziness
Narrative
Description of Event or Problem
PT WAS TREATED FOR DIABETIC FOOT ULCER. PT'S 25TH TREATMENT WITH HISTORY OF SINUS CONGESTION. THE DOOR LATCH DISLODGED, RESULTING IN SUDDEN DECOMPRESSION OF THE CHAMBER. PT C/O COMPLAINED OF LIGHT HEADEDNESS AND EAR TENDERNESS. STAFF NOTIFIED VENDOR ABOUT THE INCIDENT AND PAN-AMERICA HYPERBARICS INC RESPONDED WITH A SITE VISIT WITHIN 24 HOURS. PAHI REPLACED THE OUTER STEEL LATCH HANDLE AND ULTIMATELY REPLACED THE ENTIRE DOOR LATCH OF THIS CHAMBER AND THE OTHER HYPERBARIC OXYGEN CHAMBER.======================MANUFACTURER RESPONSE FOR HYPERBARIC OXYGEN CHAMBER, PAHI HBO CHAMBER======================MANUFACTURER FIXED THE DOOR.