Catalog Number MK06000 |
Device Problems
Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959); No Pressure (2994)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided within a follow-up report.
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Event Description
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In was reported that during use on patient the screen turned white for a few seconds.Afterwards the curves reappeared and the touch function worked again.No 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 related to a disturbance of the medibus interface.Since similar cases have been reported capa 95652 was opened to consolidate the analyses.The investigation finally revealed that the issue can be attributed 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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