Catalog Number 8604700 |
Device Problems
Disconnection (1171); Gas Output Problem (1266); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The dispatched dräger service engineer confirmed the reported ventilator failure upon log file review.The recorded error codes indicated that the auxiliary vacuum pressure went out of range.The vacuum pump did not exhibit any deviation from specification during testing and, the vacuum pressure did not fully collapse.Facts from which could be concluded that the leak in the system was rather small.A loose valve actuator tube could be identified as the most likely root cause.The auxiliary vacuum pressure is needed to actuate the valves that control the ventilation and to keep the ventilator diaphragm in place during piston movement.With a vacuum pressure out of range the diaphragm may become dislodged which can cause severe mechanical damages to the ventilator unit.Furthermore, the control of the ventilation cycles may be disturbed significantly.Hence, the device is designed to shut down automatic ventilation and to post a corresponding alarm; manual ventilation with the built-in breathing bag remains possible.The vacuum pump has been replaced as a precautionary measure; the device was tested and returned to use.
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Event Description
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It was reported that the device exhibited a ventilator failure during use.The patient was connected to a replacement device; no health consequences have occurred.
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Event Description
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It was reported that the device exhibited a ventilator failure during use.The patient was connected to a replacement device; no health consequences have occurred.
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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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