Catalog Number MK06000 |
Device Problems
Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.We will provide results in a separate final report.
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Event Description
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It was reported that during use of the perseus the screen froze, became white and the patient's ventilation was disturbed.The device reportedly rebooted and upon restarting, ventilation resumed, and the screen was functional.There was no serious injury reported.
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Manufacturer Narrative
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The electronic log file was available for investigation.The information stored there indicates that the root cause for the observed device behavior was due to an already known vulnerability of the medibus interface software module.The medibus interface of the perseus a500 was disrupted by external non-medibus-compliant data packages such that the internal processor became overloaded.This resulted in delays to the display of ventilation curves on the screen of the perseus, and subsequently the devices in question performed warm starts.As a result, the ventilation pressure dropped and ventilation was interrupted for a few seconds before therapy was resumed with the same settings as before.The issue is due to a vulnerability within the perseus sw versions 2.0n.The software sub module for the medibus interface has already been improved and will be distributed as part of the new perseus software release 2.03.The distribution of the sw2.03 will be carried out with this field safety corrective action.All customers of draeger perseus a500 anesthesia machines equipped with sw2.0n will be informed with a field safety notice about the identified risk.All devices equipped with the affected sw versions 2.0n will be upgraded to sw2.03.
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Event Description
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Please refer to the initial-report.
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Search Alerts/Recalls
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