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

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded in a follow up report.
Event or Problem Description
It was reported that on (b)(6) at approximately 2:52 pm, the perseus restarted unexpectedly during anesthesia, after approximately 3¿3½ hours of use.Before restarting, the perseus played an acoustic alarm.No injury reported.
Additional Manufacturer Narrative
The logfile analysis carried out by the manufacturer revealed that on the reported day of event (february 2nd, 2026) a communication interrupt between the two processors onboard the therapy control unit have occurred during use.The device is designed to trigger a system reboot when such condition occurs.In case of such a reset, therapy will be interrupted for approximately 15 seconds.Afterwards, therapy will be continued with the last valid settings.Also in the particular case, the device behaved as specified after the reset and ventilation was continued without further problems until the case was completed by switching 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.As a precautionary measure, it was recommended to replace the respective board.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
Event or Problem Description
It was reported that on monday, february 2nd at approximately 2:52 pm, the perseus restarted unexpectedly during anesthesia, after approximately 3¿3½ hours of use.Before restarting, the perseus played an acoustic alarm.No injury reported.

• 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: 24412606
• Report Number: 9611500-2026-00075
• Device Sequence Number: 21484818
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180516(93)MK06000-34
• 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): 04/17/2026

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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2018
• 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