Catalog Number 8606500 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/08/2021 |
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 during a case that the unit displayed a mixer failure error.Based on the log analysis the mixer failure was accompanied by a ventilator failure.There was no patient injury reported.
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Event Description
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It was reported during a case that the unit displayed a mixer failure error.Based on the log analysis the mixer failure was accompanied by a ventilator failure.There was no patient injury reported.
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Manufacturer Narrative
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The log file was analyzed whereby it was determined that the device passed the automatic power-on self-test (post) in the morning of the date of event without deviations.After 6 minutes into the case the self-monitoring function detected a communication problem between the cpu board that controls the gas dosage and the user interface.In a situation where ventilator and gas mixer enter a fail state simultaneously the supervisor software routine is designed to switch-off both subsystems.The device went into the so-called "safety mode" and alerted the user to this condition by means of a corresponding alarm.If such deviation would occur during use the user has to set up adequate oxygen and a-gas flows manually to perform manual ventilation with the in-built breathing bag; monitoring functionalities of the device are not affected by this kind of error condition.The procedure how to establish the emergency gas supply is laid down in the ifu.Dräger knows a certain number of similar events - none of these events could be traced back to a clear root cause.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 is within the expected range of the respective risk assessment and thus accepted.
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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 unit displayed a mixer failure error.Based on the log analysis the mixer failure was accompanied by a ventilator failure.There was no patient injury reported.
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Search Alerts/Recalls
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