HYPERBARIC CHAMBER 3600E/ER
Received Sep 17, 2017 · Event occurred Jun 26, 2017
Report 2020676-2017-00023 · MDR key 6871400
Device
Product problems
- Improper Device Output
- Improper Device Output
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SECHRIST TECHNICIAN WAS DISPATCHED ONSITE AND EVALUATED DECOMPRESSION AND EMERGENCY VENT ON THE CHAMBER. TECHNICIAN FOUND THAT EXHAUST SCREEN WAS DIRTY, REMOVED SCREEN AND CHAMBER DECOMPRESSES NORMALLY. TECHNICIAN INSTRUCTED CUSTOMER TO REMOVE, INSPECT SCREEN AND CLEAN OUT AT LEAST ONCE MONTH. A DEVICE HISTORY REVIEW WAS PERFORMED (DHR) CHAMBER 3600E/ER SERIAL NUMBER (B)(4) WAS MANUFACTURED ON 03/12/2006. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
Description of Event or Problem
SECHRIST IS SUBMITTING THIS MEDWATCH REPORT IN RESPONSE TO MEDSUN REPORT # (B)(4). ON (B)(6) 2017 CUSTOMER REPORTED DECOMPRESSION ISSUES WITH THEIR HYPERBARIC CHAMBER 3600E/ER. CUSTOMER STATED THAT THE EMERGENCY VENT IS SLOW AND DECOMPRESSION RATE IS ALSO SLOW.