MalfunctionBTM
AIRFLOW
Received Feb 28, 2019 · Event occurred Jan 25, 2019
Report 1314417-2019-00006 · MDR key 8377953
Device
Product problems
- Connection Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AFFECTED PRODUCT WAS NOT RETURNED. BATCH RECORD WAS REVIEWED AND NO ABNORMALITIES FOUND. SAMPLES FROM INVENTORY WERE INSPECTED, PICTURES OF EACH OF THE MASK PORTS TAKEN, SHOWING THEY WERE CONFORMING. EACH PART WAS ABLE TO FIT ON THE PATIENT PORT EASILY. NO OUT OF ROUND PORTS WERE FOUND. INVESTIGATION IS INCONCLUSIVE.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "MASK CONNECTION MISSHAPEN AND CANNOT BE ATTACHED TO RESUS BAG." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.