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

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
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 screen froze and could not be operated during a case.The device emitted a loud intermittent high-frequency beeping.The patient was immediately ventilated manually and a replacement device was used.There was no patient injury reported.
Additional Manufacturer Narrative
Based on the logfile analysis, the case in question could be reconstructed and the reported symptom could be traced using the logfile records.However, based on the analysis, the exact root cause could not be determined and there were also no indications for the pba therapy control unit m16.2 causing the problem.Nevertheless, the replacement of the m16.2 was recommended as a precautionary measure, and the pba was returned for investigation.Components other than the m16.2 could be excluded as root cause as a device shutdown would then have to be caused by a permanent hardware failure and the device could be put back into operation after the replacement.Based on the investigation of the replaced pba in a lab device, no deviations from the specification were found either.The device including the pba was operated for a total of 7 days in alternating operating modes with different settings and system tests being carried out at irregular intervals.There were no indications for a malfunction found and the reported symptom could not be reproduced.Dräger finally concludes that most likely, the reported failure was caused by a failed reset at the processor level of the pba m16.2, although no corresponding information could be found in the logs.In the case of a complete failure of the device, automatic ventilation is no longer possible, electronic gas dosage as well as device and patient monitoring are out of function.An acoustic alarm is given (continuous alarm tone generated by the secondary alarm system), indicating the failure to the user.Continuation of therapy remains possible by using the o2 safety flow (electronically controlled gas mixer) or the flow control valves (mechanically controlled gas mixer) for a manual ventilation.
Event or Problem Description
It was reported that the device screen froze and could not be operated during a case.The device emitted a loud intermittent high-frequency beeping.The patient was immediately ventilated manually and a replacement device was used.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: 24035676
• Report Number: 9611500-2026-00009
• Device Sequence Number: 13026116
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)221021(17)230228(93)MK06000-41
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/03/2026

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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