MalfunctionOHP
PROVENT SLEEP THERAPY
Received May 1, 2017 · Event occurred May 1, 2016
Report 3011683122-2017-00001 · MDR key 6534628
Device
Generic name
Provent 30 Night Starter Kit
Manufacturer
Provent Sleep Therapy, LlcModel number
CAT1114Catalog number
CAT1114
Lot number
34061-S07
Product problems
- Detachment Of Device Component
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS MANUFACTURED TO SPECIFICATION. NO ABNORMALITIES NOTED.
Description of Event or Problem
USER NOTICED THE VALVE FLAPS MISSING FROM THE DEVICE UPON WAKING IN THE MORNING. IT IS UNKNOWN WHETHER THE DEVICE WAS DEFECTIVE BEFORE USE OR IF THE FLAPS DETACHED DURING USE.