Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Device Sensing Problem (2917)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was evaluated on-site.The reported ventilator failure could be confirmed and traced back to an error condition in the piston position detection system.The hub of the piston is equivalent to the tidal volume the ventilator applies.If the piston position cannot be detected anymore the device is designed to shut down automatic ventilation to protect from potentially hazardous output.The shut-down is accompanied by a corresponding alarm; manual ventilation and the monitoring functions remain available to the full extent.The dräger service engineer replaced the photodetector in the light barrier system to rectify the problem.The device passed all consecutive tests and could be returned to use.Dräger finally concludes that the system responded as designed upon the malfunction of a single component that occurred after 16 years of use.
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Event Description
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It was reported during a case that the device displayed a ventilator failure message.There was no patient 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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Event Description
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It was reported during a case that the device displayed a ventilator failure message.There was no patient injury reported.
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Search Alerts/Recalls
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