AIRFLOW
Received Mar 26, 2019 · Event occurred Sep 1, 2018
Report 1314417-2019-00010 · MDR key 8452320
Device
Product problems
- Failure to Disconnect
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE AFFECTED PRODUCT WAS NOT RETURNED. FUNCTIONAL EVALUATION OF THE PRODUCT FOUND NO ISSUES FOR EXISTING INVENTORY, ALTHOUGH THE REPORTED LOT WAS NOT AVAILABLE. A LOOKBACK AT RESUS BAGS FOR THE PAST TWO YEARS SHOWS 1 COMPLAINT FOR MASKS GETTING STUCK TO THE PORT OF THE RESUS BAG. OVER THE LAST 2 YEARS THERE HAVE BEEN 0 NC'S RELATED TO MASKS GETTING STUCK TO THE PORT OF THE RESUS BAGS. THERE IS NO AVAILABLE EVIDENCE TO SUPPORT THERE IS A PRODUCT ISSUE FORM THIS COMPLAINT.
Description of Event or Problem
THE CUSTOMER ALLEGES THE " MASK WOULD NOT DISCONNECT FROM THE RESUS BAG". NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.