MalfunctionBTM
AIRFLOW
Received Feb 19, 2019 · Event occurred Jan 15, 2019
Report 1314417-2019-00005 · MDR key 8349694
Device
Product problems
- Activation, Positioning or Separation 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 AND DISCONNECT WITHOUT ABNORMAL FORCE. NO OUT OF ROUND PORTS WERE FOUND. INVESTIGATION IS INCONCLUSIVE.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "MASK WILL NOT DETACH FROM THE BAG." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.