PERRY HYPERBARIC CHAMBER
Received Jun 12, 2002 · Event occurred Jun 4, 2002
Report 1036464-2002-00001 · MDR key 399680
Device
Generic name
Hyperbaric Chamber
Manufacturer
Perry Baromedical Corp.Model number
SIGMA II-4Catalog number
NA
Lot number
NA
Product problems
- Break
- Misassembled
Patient
19 YR
- Death
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
EVENTHOUGH THE CHAMBER WAS NOT PRESSURIZED AND IN OPERATION AND THE DOCTOR DOES NOT FEEL THE INCIDENT IS RELATED TO THE COMPANY'S DEVICE, THE COMPANY FEELS IT IS APPROPRIATE TO FILE THIS REPORT AS REPORTED TO THE COMPANY: CAR ACCIDENT PATIENT WAS DIRECTLY TRANSFERRED FROM THE EMERGENCY ROOM TO THE HYPERBARIC CHAMBER ROOM. PATIENT WAS ON ENDOTRACHEAL TUBE. A DOCTOR CONNECTED THE O2 GAS SUPPLY FROM THE CHAMBER WITH A FLOW RATE OF 30 1PM, TO EXHAUST CONNECTOR OF THE AMBU (MANUAL RESUSCITATOR). "WITHIN A FEW SECONDS THE PATIENT'S LUNG EXPLODED AND THE ENDOTRACHEAL TUBE BROKE." WHEN THIS INCIDENT OCCURRED THE CHAMBER DOOR WAS NOT CLOSED AND NO CHAMBER PRESSURE WAS USED. DOCTOR WAS PRESENT WITH THE PATIENT.