MalfunctionBYP
IN CHECK DIAL
Received Mar 9, 2016 · Event occurred Feb 24, 2016
Report MW5060842 · MDR key 5495439
Device
Product problems
- Detachment Of Device Component
- Device Operates Differently Than Expected
Patient
57 YR
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
SUBJECT PARTICIPATING IN (B)(6). DURING VISIT, SUBJECT WAS TO COMPLETE PIFR TEST PER PROTOCOL. WHEN SUBJECT TOOK INHALATION BREATH WITH DEVICE IN MOUTH, CIRCULAR VALVE ON ATTACHMENT BECAME DETACHED AND WAS SUCKED INTO SUBJECT'S THROAT. SUBJECT WAS ABLE TO COUGH TO BRING PIECE OUT OF MOUTH. MANUFACTURER AWARE.