ANÄSTHESIESET VENTSTAR BASIC 1,8M
Received Mar 23, 2021 · Event occurred Feb 28, 2021
Report 9611500-2021-00120 · MDR key 11553650
Device
Product problems
- Material Disintegration
- Gas/Air Leak
- Material Disintegration
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION WAS JUST STARTED. THE RESULTS WILL BE FORWARDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT WHEN USING THE BREATHING CIRCUITS THE BLUE CONNECTOR DETACHES FROM THE TUBE. NO INJURY REPORTED.
Description of Event or Problem
IT WAS REPORTED THAT WHEN USING THE BREATHING CIRCUITS THE BLUE CONNECTOR DETACHES FROM THE TUBE. NO INJURY REPORTED.
Additional Manufacturer Narrative
UNFORTUNATELY, THE USER WAS UNABLE TO PROVIDE AN AFFECTED HOSE SYSTEM FOR THE INVESTIGATION, AS THESE HAD ALREADY BEEN DISPOSED OF. THEREFORE, A CASE-SPECIFIC EVALUATION WAS NOT POSSIBLE, SO THAT THE CAUSE FOR THE DETACHMENT OF THE BLUE CONNECTOR COULD NOT BE DETERMINED. IN GENERAL, THE FAILURE (BROKEN BOND) CAN BE CAUSED BY A TOO SMALL AMOUNT OF ADHESIVE. INCORRECT HANDLING, IN WHICH THE CONNECTORS ARE TOUCHED AND TURNED ON THE BOND AND NOT ON THE CORRUGATION, IS ALSO A CONCEIVABLE ROOT CAUSE OF THE ERROR PATTERN FOUND. IF A RELEVANT LEAKAGE OCCURS DUE TO A LOOSE CONNECTION, IT WILL BE DETECTED DURING LEAK-TEST THAT MUST BE PERFORMED PRIOR TO EACH PATIENT USE. IN CASE A RELEVANT LEAKAGE SUDDENLY OCCURS DURING USE, CORRESPONDING ALARMS WILL BE GIVEN.