MalfunctionCAO
MALLINCKRODT
Received May 2, 2017 · Event occurred Apr 5, 2017
Report 2936999-2017-05170 · MDR key 6536039
Device
Generic name
Airway, Esophageal (obturator)
Manufacturer
Mmj Sa De Cv (usd)Model number
5-18541Catalog number
5-18541
Lot number
13I0332JZX
Product problems
- Inflation Problem
- Inflation Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
MEDTRONIC RECEIVED A COMMUNICATION REGARDING A COMBITUBE 41 FR TRAY. THE CUSTOMER REPORTED THAT THE CUFF HAD BREAKAGE. THE CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.