SUNMED LLC
Received Feb 16, 2024 · Event occurred Jan 15, 2024
Report 1314417-2024-00012 · MDR key 18727884
Device
Generic name
Small Adult Airflow W/manometer
Manufacturer
Sunmed Holdings LlcModel number
AF5140MBCatalog number
AF5140MB
Lot number
462079
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COULD DELAY RESUSCITATION OF THE PATIENT.
Description of Event or Problem
THE END OF THE RESUSCITATION BAG POPPED OFF.
Additional Manufacturer Narrative
COULD DELAY RESUSCITATION OF THE PATIENT. THE COMPLAINT OF THE END OF THE RESUSCITATION BAG POPPING OFF INVOLVING PART AF5140MB WAS CONFIRMED. A ROOT CAUSE WAS DETERMINED TO BE THE MANUAL ASSEMBLY OPERATION WAS NOT CONDUCTED PROPERLY. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE SERIOUS / CAPA OPTIONAL, WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.
Description of Event or Problem
THE END OF THE RESUSCITATION BAG POPPED OFF.