BARA-MED
Received Oct 18, 2016 · Event occurred Sep 13, 2016
Report 6036511 · MDR key 6036511
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Environmental Tectonics Corp.Model number
N/ACatalog number
N/A
Lot number
N/A
Product problems
- Break
- Detachment Of Device Component
Patient
79 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHEN THE TECHNICIAN WENT TO CLOSE THE DOOR TO THE CHAMBER AND BEGIN THE PATIENT'S TREATMENT, THE HANDLE BROKE OFF AND THE PATIENT WAS TRAPPED IN THE CHAMBER. THE TECHNICIAN CALLED THE CLINICAL COORDINATOR AND THE PROGRAM MANAGER IMMEDIATELY. MAINTENANCE WAS CALLED AND THE PATIENT WAS REMOVED FROM THE CHAMBER AFTER 20 MINUTES OF BEING IN THERE. THE MANUFACTURER WILL ALSO BE CALLED IN TO MAKE SURE THAT THE MACHINE IS SAFE FOR PATIENT USE BEFORE WE RESUME TREATMENTS. MANUFACTURER RESPONSE FOR HYPERBARIC CHAMBER, HYPERBARIC CHAMBER (PER SITE REPORTER): NOTIFIED AND EVALUATED CHAMBER.