Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Sense (1559); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation was just started.The result will be forwarded in a follow up report.H3 other text : on-going.
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Event Description
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It was reported that ventilation stopped during use.Manual ventilation was possible.No patient injury reported.
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Manufacturer Narrative
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Log file evaluation performed by the manufacturer confirms the reported behavior: the supervisor function detected a sporadic loss of the signal from the sensor that monitors the inspiratory cylinder pressure.To protect the patient from potentially hazardous output the device is designed to shut-down automatic ventilation and to post a corresponding "ventilator failure" alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible; the monitoring functions are still available as well.Dräger finally concludes that the workstation responded as designed upon the deviation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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It was reported that ventilation stopped during use.Manual ventilation was possible.No patient injury reported.
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Search Alerts/Recalls
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