SUNMED HOLDINGS LLC
Received Oct 17, 2022 · Event occurred Sep 20, 2022
Report 1314417-2022-00020 · MDR key 15614750
Device
Generic name
Small Adult Airflow W/manometer
Manufacturer
Sunmed Holdings LlcModel number
AF5140MBCatalog number
AF5140MB
Product problems
- Defective Component
- Difficult to Open or Close
- Defective Component
- Difficult to Open or Close
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DUCKBILLED VALVE WOULDN'T OPEN DURING A CODE.
Additional Manufacturer Narrative
A DUCKBILL NOT OPENING DURING CODE WOULD LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET SUMMARY: RETURNED PRODUCT CONFIRMED THE COMPLAINT. DURING INVESTIGATION OF THE DEVICE WITHOUT A MANUFACTURING DATE/LOT NUMBER, IT WAS FOUND THAT THE DEVICE WAS MADE PRIOR TO CERTAIN ENGINEERING CHANGES DATING TO 2015. RA: RMA-20020 CONTAINS APPROPRIATE RISK ASSESSMENT. PREVIOUS CORRECTIVE ACTIONS OF CAPA14-016 AND MI-CO19-0225 ADDRESS THE NON-CONFORMANCE IDENTIFIED BY THIS COMPLAINT.
Description of Event or Problem
THE DUCKBILLED VALVE WOULDN'T OPEN DURING A CODE.
Additional Manufacturer Narrative
A DUCKBILL NOT OPENING DURING CODE WOULD LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET