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); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the machine ventilator would run and stop with a break in-between.No patient injury reported.
Additional Manufacturer Narrative
The electronic device logfile has been analyzed with regards to the reported event.The case in question could be reconstructed based on the stored entries.On 2026-02-19 the device successfully passed the system test at 5:58am.The case in question was started at 7:37am using man/spont and continued in volume control af from 7:55am.The following ventilation was unremarkable.Beginning around 10:35am the user switched multiple times between man/spont and various automatic ventilation modes.In the following leaks have been detected in the patient circuit, which have led to a lack of fresh gas.The device repeatedly alarmed minute volume low and fresh gas low or leakage.At 11:18am the unit was placed in standby.The analysis of the device logfile records has given no hints for a malfunction of the device.Towards the end of the procedure a circuit leak led to minor restrictions of ventilation.During the case in question, no functional limitations of the patient gas measurement are apparent.In case of decreased tidal volume and/or airway pressure, e.G.Caused by a significant circuit leak, the sufficient ventilation and oxygenation of the patient might be restricted.During system test and leak test as well, internal and external leakages are detected and depending on size a conditional (yellow) or non-functional (red) state is the consequence.Based on leakage, fresh gas flow settings and set alarm limits during ventilation several audible and visible alarms would be issued (e.G.Apnea, minute volume low, volume/airway pressure not achieved).The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.On the basis of the available investigation results, the case is subsequently assessed as not reportable.
Event or Problem Description
It was reported that the machine ventilator would run and stop with a break in-between.No patient 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: 24588856
• Report Number: 9611500-2026-00105
• Device Sequence Number: 9193960
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)191206(93)MK06000-38
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/28/2026

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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• 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
• Patient Sex: Unknown