Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided with a follow-up report.
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Event Description
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It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
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Event Description
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It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
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Manufacturer Narrative
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The investigation was carried out based on evaluation of the electronic log file.A sporadic malfunction of a cpu board which controls the device-internal communication between user interface and vgc (ventilation and gas controller) was identified to be root cause of the reported failure.This leads to a shutdown of the ventilator and gas mixer.In this situation, the device automatically switches to monitoring mode while alarming the user to this condition by means of a corresponding alarm.For the actual case, the unit was on standby - a patient was not connected.As described in the ifu manual ventilation with emergency oxygen dosage remains possible including the application of anesthetic gas as well.Dräger finally concludes, that the device has reacted according to its safety concept and has performed an emergency shutdown of the affected components accompanied by the respective alarms.Similar cases are known ¿ however, the exact failure mechanism could not be determined during in-depth analysis.It was only possible to narrow down the root cause to the respective pcb.The fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application periphery makes a general design issue rather unlikely.A reasonable explanation would be electrostatic discharge of the user during interaction with the device or any other kind of electromagnetic disturbance that exceeds the immunity barriers of the device.The primus was developed in compliance to the requirements of iec 60601-1-2.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 during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
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Manufacturer Narrative
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Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
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Search Alerts/Recalls
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