MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Model Number MK06000

Device Problems Gas Output Problem (1266); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The results will be provided in a follow-up report.

Event Description

It was reported that the device was in use in a surgery, when the curves started to go slower and slower, the user could see more pulses/ventilation periods on the screen than normal.The users was just about to change picture/view on the device when suddenly the screen went grey.According to the user the ventilation also stopped.The user was just about to start manual ventilation, when the screen came back on(user estimates around 10-20 seconds) and ventilation started again.No injury reported.

Manufacturer Narrative

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 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.As also reported, the ventilation could be resumed after the reboot without further problems.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 (b)(6) 2020 about the identified risk.All devices equipped with the affected sw versions 2.0n will be upgraded to sw2.03.

Event Description

It was reported that the device was in use in a surgery, when the curves started to go slower and slower, the user could see more pulses/ventilation periods on the screen than normal.The users was just about to change picture/view on the device when suddenly the screen went grey.According to the user the ventilation also stopped.The user was just about to start manual ventilation, when the screen came back on(user estimates around 10-20 seconds) and ventilation started again.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11587692
• MDR Text Key: 244182236
• Report Number: 9611500-2021-00136
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)190923(93)MK06000-37
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MK06000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.