Model Number MK06000 |
Device Problems
Decrease in Pressure (1490); Device-Device Incompatibility (2919); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
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 the perseus a500 displayed double the frequency as set.Shortly after, the device performed a reboot.The device was replaced.No injury reported.
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Manufacturer Narrative
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Based on the logfile analysis, an already known vulnerability of the perseus medibus interface was determined to be the root cause of the reboot.The reboot was obviously caused by large medibus incompatible data packages leading to a processor overload and finally to a reboot.Only sw versions 2.0n are affected by the identified medibus vulnerability.The reboot results in a short-term outage of therapy functions for not more than 15 seconds accompanied by a corresponding alarm, before the therapy is resumed with the last valid settings.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 a field safety corrective action.All customers of draeger perseus a500 anesthesia machines equipped with sw2.0n were informed with a field safety notice in june 2020 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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It was reported that the perseus a500 displayed double the frequency as set.Shortly after, the device performed a reboot.The device was replaced.No injury reported.
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Search Alerts/Recalls
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