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

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported: "during the anaesthesia of an 18-year-old male patient in operation north 2, the department of anaesthesia & surgery north, aarhus university hospital, a loud whining noise suddenly emanated from the anaesthesia machine, and the entire screen went black.The fault lasted approx.3 seconds and recurred twice during the anaesthesia.After the two episodes, the screen returned to normal display, although some of the figures appeared light grey.The machine then displayed a message stating "flow sensor calibration required".The device had previously been tested and used on several patients without any problems.During the periods of malfunction, the anaesthesia system¿s function was temporarily unavailable, which could potentially have resulted in a failure to detect changes in the patient¿s condition or in the composition of the anaesthetic gas.Consequences were avoided because action was taken.".

• Brand Name: PERSEUS A500
• Common Device Name: ANESTHESIA UNIT
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24902352
• Report Number: 9611500-2026-00155
• Device Sequence Number: 9727505
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)190114(93)MK06000-36
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K133886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown