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

Model Number MK06000

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

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

Event Date 08/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ventilator failed during use.There was no patient 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 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.For this case, the update to sw2.03 was discussed with the customer to be performed within the next weeks in the course of the planned maintenance.

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12479063
• MDR Text Key: 272692040
• Report Number: 9611500-2021-00391
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170425(17)180203(93)MK06000-33
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1