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

Catalog Number MK06000

Device Problems Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.We will provide results in a separate final report.

Event Description

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.

Manufacturer Narrative

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.

Event Description

Please refer to the initial-report.

• 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: 9818064
• MDR Text Key: 183151428
• Report Number: 9611500-2020-00076
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1