SUNMED HOLDINGS LLC
Received Nov 18, 2022 · Event occurred Sep 11, 2022
Report 1314417-2022-00021 · MDR key 15827984
Device
Generic name
Small Adult Airflow W/manometer
Manufacturer
Sunmed Holdings LlcModel number
AF5140MBCatalog number
AF5140MB
Lot number
UNKNOWN
Product problems
- Defective Component
- Defective Component
Patient
25 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
REPORTABLE AS NOT ABLE TO PROVIDE RESPIRATORY SUPPORT TO THE PATIENT. THE BVM MALFUNCTIONING WOULD POTENTIALLY 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
BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON.
Additional Manufacturer Narrative
REPORTABLE AS NOT ABLE TO PROVIDE RESPIRATORY SUPPORT TO THE PATIENT. THE BVM MALFUNCTIONING WOULD POTENTIALLY LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.
Description of Event or Problem
BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON.