MalfunctionCAO
MALLINCKRODT
Received Sep 2, 2015
Report 2936999-2015-00773 · MDR key 5051322
Device
Product problems
- Deflation Problem
- Inflation Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE, THERE WAS AN INFLATION/DEFLATION ISSUE WITH THE CUFF. THERE IS NO REPORT OF PATIENT INVOLVEMENT AND NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
(B)(4). THE MANUFACTURING GUIDELINES AND CONTROLS WERE REVIEWED AND FOUND EFFECTIVE TO DETECT THIS TYPE OF FAILURE MODE. THE REPORTED MALFUNCTION IS NOT RELATED TO THE MANUFACTURING PROCESS.