Catalog Number 8603800 |
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 08/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation was just startet, the result will be provided in a follow-up report.
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Event Description
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It was reported that on (b)(6) 2021, the machine passed the power-on self-test, and after a few seconds of standby, the machine was found to be faulty, such as ventilator fault, gas transmission fault, setting canceled, wireless identification function fault, etc.No injury reported.
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Manufacturer Narrative
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The log file was analyzed whereby it could be confirmed that, as described in the user's report, the device passed the automatic power-on self-test (post) in the morning of the date of event without deviations.The log file further indicates that the self-monitoring function detected a communication problem between the cpu board that controls the gas dosage and the user interface during the concerned surgical procedure.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 occurs during use the user has to set up an adequate oxygen and a-gas flow 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.A check of the measures that are installed in the hospital to prevent from the effects of emc disturbances is recommended.
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Event Description
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It was reported that on august 20, 2021, the machine passed the power-on self-test, and after a few seconds of standby, the machine was found to be faulty, such as ventilator fault, gas transmission fault, setting canceled, wireless identification function fault, etc.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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Event Description
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It was reported that on august 20, 2021, the machine passed the power-on self-test, and after a few seconds of standby, the machine was found to be faulty, such as ventilator fault, gas transmission fault, setting canceled, wireless identification function fault, etc.No injury reported.
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Search Alerts/Recalls
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