Catalog Number MK06000 |
Device Problems
Gas Output Problem (1266); Decrease in Pressure (1490); No Pressure (2994); Intermittent Communication Failure (4038)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2020 |
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 that during an anesthesia the alarm "ventilator failure" was posted.No injury reported.
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Event Description
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It was reported that during an anesthesia the alarm "ventilator failure" was posted.No injury reported.
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Manufacturer Narrative
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The evaluation of the log file revealed that - during the concerned procedure - a sudden communication interrupt between the two processors of the board that controls the therapy functions has occurred.The device is designed to initiate a reboot to remove this error condition.The device will briefly power off and back on; the user will be alerted by means of a corresponding alarm.After the reboot which will typically be finished latest after 15 seconds the operation will be continued with the last valid settings.In the particular case the procedure was finished; the user has placed the unit into standby 43 minutes later.The therapy control board has been replaced as a precaution although it is seen likely that no hardware error has occurred.Finally - although it is evident that an internal communication problem with the particular pcb was the source of deviation - the triggering conditions remain unknown since log recording stopped with occurrence of the deviation.Dräger concludes that the device behaved as designed for such error condition - a reboot was triggered to resume therapy and the user was alerted to this condition by means of a corresponding alarm.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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Search Alerts/Recalls
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