VEEVO INTERMITTANT/CONTINUOUS 1500 SERIES
Received Aug 12, 2016 · Event occurred Dec 21, 2015
Report 5871399 · MDR key 5871399
Device
Generic name
Regulator, Vacuum - Tenacore Vacuum Regulator
Manufacturer
Tenacore Holdings, Inc.Model number
TWSA1500Catalog number
TWSA1500
Product problems
- Crack
- Suction Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BIOMED WENT TO THE SURGICAL ICU TO INVESTIGATE THE CONTINUOUS/INTERMITTENT SUCTION REGULATORS. FOUND THE OHIO MEDICAL AND THE OHMEDA MEDICAL SUCTION REGULATORS TO BE WORKING PROPERLY, BUT THE TENACORE SUCTION REGULATORS TESTED DID NOT WORK IN THE INTERMITTENT MODE. BIOMED OPENED ONE OF THE BROKEN TENACORE SUCTION REGULATORS AND FOUND THE RUBBER GASKET WAS CRACKED CAUSING THE SUCTION GAUGE TO LOSE ITS INTERMITTENT FUNCTION. BIOMED CHECKED ALL TENACORE SUCTION REGULATORS IN THE WHOLE MEDICAL CENTER AND FOUND SEVERAL WITH THIS ISSUE.