MalfunctionKDP
REGULATOR, VACUUM
Received Feb 9, 2017 · Event occurred Dec 9, 2016
Report 6313781 · MDR key 6313781
Device
Generic name
Regulator, Vacuum
Manufacturer
Boehringer Laboratories, LlcProduct problems
- Component Incompatible
- Inadequate Instructions for Healthcare Professional
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE BOEHRINGER SUCTION REGULATORS COME WITH A METAL SAFETY TETHER. ACCORDING TO THE INSTRUCTIONS FROM THE MANUFACTURER, THE TETHER IS TO BE ATTACHED TO THE SUCTION OUTLET. HOWEVER, THAT IS A VIOLATION OF NFPA-99 CODE. MANUFACTURER RESPONSE FOR SUCTION REGULATOR SAFETY TETHER, (BRAND NOT PROVIDED) (PER SITE REPORTER): WE HAVE ASKED THE REP TO REMOVE ALL THE TETHERS HE CAN FIND. WE WILL NOT ORDER THE TETHERS WHEN WE ORDER ADDITIONAL REGULATORS. WE WILL REMOVE ANY MISSED TETHERS AND HAVE COMMUNICATED THIS TO THE NURSING STAFF.