MalfunctionCAO
MALLINCRODT
Received Sep 24, 2014 · Event occurred Sep 1, 2014
Report 2936999-2014-00849 · MDR key 4113256
Device
Product problems
- Inflation Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER WAS ASKED BUT UNKNOWN. WITHOUT THE LOT NUMBER, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem
COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER STATING THAT DURING PRE-USE TESTING, THE CUFF ON A COMBITUBE WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.