MONOPLACE HYPERBARIC CAHMBER 32"
Received Nov 16, 2012 · Event occurred Oct 18, 2012
Report 2020676-2012-00050 · MDR key 2857513
Device
Generic name
Hyperbaric Chamber 32"
Manufacturer
Sechrist Industries, Inc.Model number
3200Catalog number
3200
Product problems
- Decrease in Pressure
- Malposition of Device
- Gas/Air Leak
- Noise, Audible
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HYPERBARIC TECHNICIAN WAS COMPRESSING THE CHAMBER TO 3 ATA AT RATE OF 1.5 PSI/MIN DURING A SCHEDULED TESTING. WHEN THE CHAMBER REACHED 2.5 ATA THE TECHNICIAN HEARD A LOUD POP AND GAS ESCAPING FORM THE CHAMBER. THEN THE CHAMBER RAPIDLY DECOMPRESSED. THE TECHNICIAN SHUT OFF THE GAS SUPPLY TO THE CHAMBER. AN INITIAL OBSERVATION WAS COMPLETED BY THE HYPERBARIC TECHNICIAN AND REPORTED TO THE MANUFACTURER. THE DOOR HANDLE HAD MOVED 90 DEGREES TOWARD THE OPEN POSITION. THE SWING ARM DID NOT MOVE BEYOND THE OPEN POSITION AND HELD THE DOOR IN PLACE. THE DOOR GASKET WAS BLOWN OUT OF PLACE AND CRUMPLED IN THE LIMITED SPACE BETWEEN THE DOOR AND SWING ARM. IMMEDIATELY AFTER THE INCIDENT THE CHAMBER WAS TAKEN OUT OF SERVICE. THE CHAMBER WAS EVALUATED AND PHOTOGRAPHED BY A REPRESENTATIVE OF THE MANUFACTURER, WHO WENT TO THE CUSTOMER'S FACILITY, (B)(4) 2012. DURING THE EVALUATION A LOANER HYPERBARIC CHAMBER WAS INSTALLED SO THAT THIS CHAMBER COULD BE SENT BACK TO THE MANUFACTURER AND TESTED.
Additional Manufacturer Narrative
THE HYPERBARIC CHAMBER WAS OVERHAULED BY THE MANUFACTURER IN (B)(4) 2012. THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE TEAM EVALUATING THE DEVICE IS GATHERING INFORMATION BEFORE PROCEEDING WITH THE INVESTIGATION. A PLAN OF ACTION FOR THE EVALUATION IS BEING PUT TOGETHER BEFORE THE CHAMBER IS TESTED AND TOUCHED.