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

Model Number	MK06000
Medical Device Problem Codes	Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has been started; results will be provided within the follow-up report.
Event or Problem Description
It was reported that the device stopped ventilating and alarmed for ¿turbovent 2 failure.¿.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation was performed based on the available information including the electronic log file.The reported issue could be reconstructed by means of the information recorded in the log.The reported symptom was caused by a failure of the blower pwm control signal.The device reacted as specified for this situation as it issued appropriate alarms (turbo vent 2 failure) to the user.In the case of a turbovent2 failure automatic ventilation is no longer possible and the corresponding alarm is given.Fresh gas dosage and manual ventilation remains available.All alarms, possible causes and remedies are described in the instructions for use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device stopped ventilating and alarmed for ¿turbovent 2 failure.¿ there was no patient injury reported.

• Brand Name: PERSEUS A500
• Common Device Name: 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23739991
• Report Number: 9611500-2025-00671
• Device Sequence Number: 16004841
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)201110(17)210427(93)MK06000-39
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Device Model Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Patient Sex: Unknown