Model Number MK06000 |
Device Problems
Gas Output Problem (1266); Decrease in Pressure (1490); 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 08/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow-up report.
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Event Description
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It was reported that the device alarmed during a running surgical procedure and performed a reboot.Therapy was reportedly resumed after successful completion of the reboot sequence but the operators decided to replace the device in abundance of caution.No patient consequences have reportedly occurred.
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Manufacturer Narrative
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The user was seeking dräger's assistance and provided a log file to the technical support team.Upon initial log file review it was recommended to replace the pcb which controls the therapy functions and a memory card.The device was tested afterwards and returned to use.A detailed log file review performed by the manufacturer confirmed the validity of the initial expertise - the triggering condition for the observed reboot was a communication interrupt between the two processors onboard the therapy control pcb.The reboot is the specified response to overcome this error condition; a corresponding alarm is being posted to alert the user.The log provides evidence that the remedy was successful; the device resumed therapy with previous settings after some seconds.The replaced parts were subject to a functional test but no hardware defects could be identified.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 the device alarmed during a running surgical procedure and performed a reboot.Therapy was reportedly resumed after successful completion of the reboot sequence but the operators decided to replace the device in abundance of caution.No patient consequences have reportedly occurred.
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Search Alerts/Recalls
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