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

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided with a separate follow-up-report.
Event or Problem Description
It was reported that automatic ventilation was interrupted while the device performed a restart.There was no injury reported.
Event or Problem Description
It was reported that automatic ventilation was interrupted while the device performed a restart.There was no injury reported.
Additional Manufacturer Narrative
Based on the logfile analysis, the case in question could be reconstructed and it was found that a communication interrupt between the two processors onboard the therapy control unit had occurred during the concerned procedure.The device is designed to trigger a system reboot when such condition occurs.In case of such a reset, therapy will be interrupted for a maximum of 15 seconds, the device posts a corresponding alarm to alert the user and, therapy will be continued with the last valid settings as soon as the reboot is completed.Also for the particular case, it can be confirmed that the device behaved as specified - ventilation was resumed after some seconds.The procedure could be continued without further problems until operation was finished by placing the device into standby mode.Although the source of the deviation can be attributed to the particular pcb, the exact nature of the issue cannot be determined due to its sporadic nature.The respective board was replaced as a precautionary measure, the workstation passed all consecutive tests and was returned to use without further problems reported since then.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.

• 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: 24385619
• Report Number: 9611500-2026-00069
• Device Sequence Number: 10504875
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)200722(93)MK06000-38
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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