Catalog Number 8621500 |
Device Problems
Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that the atlan switched to man/ spont two or three times on its own during operation.No patient injury was reported.
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Manufacturer Narrative
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The investigation was just started.The result will be forwarded after investigation was closed.H3 other text : on-going.
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Manufacturer Narrative
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For the investigation the provided log file was analyzed.No technical failure was found.The described ventilator failure could be reconstructed.The root cause was a pressure difference between the inspiratory and expiratory pressure values during inspiration.The atlan reacted as specified and switched to man/spont configuration in accordance with its safety concept and indicated this to the user.The reason for this may be an excessive breathing tube resistance, for example due to soaked filters or kinked tubes.The occurrence of condensation in the pneumatic circuit is a procedural problem, not related to the workstation itself.Dräger finally conclude that the measured pressure difference was a temporary problem.A hardware error is unlikely as the pressure sensors are checked regularly during the system test and during operation.The on-site check also revealed no technical failures.There is no issue with the device which would require repair or correction.Appropriate risk mitigation measures are in place; some of them are under responsibility and control of the user.The device is back in operation, no further events were reported.Based on the investigation results, the case was re-assessed as non-reportable.
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Event Description
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It was reported that the atlan switched to man/ spont two or three times on its own during operation.No patient injury was reported.
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Event Description
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It was reported that the atlan switched to man/ spont two or three times on its own during operation.No patient injury was reported.
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Manufacturer Narrative
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The investigation is still ongoing.The result will be forwarded after investigation was closed.H3 other text : on-going.
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Search Alerts/Recalls
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