SUNMED LLC
Received Feb 16, 2023 · Event occurred Dec 24, 2022
Report 1314417-2023-00005 · MDR key 16386883
Device
Generic name
Adult Airflow W/peep Valve
Manufacturer
Sunmed Holdings LlcModel number
AF1140MB-PCatalog number
AF1140MB-P
Lot number
385843
Product problems
- Break
- Material Integrity Problem
- Break
- Material Integrity Problem
Patient
Unknown
- Unspecified Respiratory Problem
- Unspecified Respiratory Problem
Narrative
Additional Manufacturer Narrative
THE BROKEN BAG WOULD DELAY THE INTUBATIONS OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE ADVERSE EVENT ORIGINATING IN THE UNITED STATES, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE NOT BEEN MET.
Description of Event or Problem
DURING INTUBATION THE BAG BROKE APART. POSSIBLE DELAY IN INTUBATION BUT NO DETAILS GIVEN ON THE PATIENT AFFECT.
Additional Manufacturer Narrative
THE BROKEN BAG WOULD DELAY THE INTUBATIONS OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE ADVERSE EVENT ORIGINATING IN THE UNITED STATES, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE NOT BEEN MET. SUMMARY: ATTEMPTS TO GET INFORMATION FROM THE END-USER WAS UNSUCCESSFUL TO DETERMINE THE LOCATION OF THE DEVICE BREAK. IT IS LIKELY THAT THE PATIENT VALVE WAS NOT FULLY CONNECTED TO THE RESUSCITATION BAG BODY. RA: RMA-20020 R37 "DEVICE CANNOT PERFORM AS INTENDED" IDENTIFIES POTENTIAL BROKEN RESUSCITATION BAGS NOT ABLE TO PERFORM AS INTENDED. NO UPDATE TO RMA REQUIRED.
Description of Event or Problem
DURING INTUBATION THE BAG BROKE APART. POSSIBLE DELAY IN INTUBATION BUT NO DETAILS GIVEN ON THE PATIENT AFFECT.