DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
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Catalog Number MS20401 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Failure to Sense (1559); Inappropriate or Unexpected Reset (2959); Unexpected Shutdown (4019)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/01/2021 |
Event Type
Death
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Manufacturer Narrative
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A follow-up report will be submitted upon completion of this investigation.
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Event Description
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It was reported that: on (b)(6) 2021, while the patient was being resuscitated, the m540 (4.1) rebooted 3 times (13h16:56 to 13h17:13, 13h18:59 to 13h19:12, 13h34:46 to 13h37:10).A rev 17 co2 cable ((b)(4)) was connected to the m540.After the 3rd reboot, the m540 went back to default setting (including views) but patient remained admitted at the central station.The involved patient died.
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Manufacturer Narrative
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Communication with the site verified that the rebooting of the m540 did not contribute to the patient event or resulting patient death.Root cause was identified as a software issue where the m540 reboots in response to receiving low accuracy messages from the etco2 pod.This issue was address via fsca tsb 15 and corrected in vg4.1.1.The site also verified that updating the device software resolved the issue of the m540 rebooting.A device reboot or shutdown is visibly obvious to the user and an audible tone is provided to alert the user.Patient monitoring is restored automatically after the reboot.In the event 3 reboots occur in under 10 minutes, the device goes into a "fail state" and a constant alarm tone is provided.A message is displayed at the associated cockpit and infinity central station (ics) indicating the m540 is disconnected/offline.
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Event Description
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It was reported that: on (b)(6) 2021, while the patient was being resuscitated, the m540 (4.1) rebooted 3 times (13h16:56 to 13h17:13, 13h18:59 to 13h19:12, 13h34:46 to 13h37:10).A rev 17 co2 cable (ref (b)(4)) was connected to the m540.After the 3rd reboot, the m540 went back to default setting (including views) but patient remained admitted at the central station.The involved patient died.
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Search Alerts/Recalls
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