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

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Inaccurate Delivery (2339); Misassembled During Installation (4049)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the vaporizer was not seated properly locked down.The patient was awake during procedure.Post-op the patient received additional medication to assist with the ¿discomfort/experience¿.
Event or Problem Description
It was reported that the vaporizer was not seated properly locked down.The patient was awake during procedure.Post-op the patient received additional medication to assist with the ¿discomfort/experience¿.
Additional Manufacturer Narrative
During on-site inspection ipm-l tests were performed and confirmed proper operation of the perseus a500 anaesthesia device.Agent output of sevo was also tested successfully.Finally, the device was tested and confirmed to be operation per manufacturer's specification.No hint for a device malfunction found.It was reported initially that the vapor 2000 sevoflurane was not seated properly and that the patient was awake.Therefore, it can be concluded that a use error not seating the vaporizer correctly has caused the awake state of the patient.The ifu of the perseus a500 describe as warning: risk due to improperly mounted vaporizers.Incorrectly mounted vaporizers can cause leakage.This can cause the fresh-gas flow to be too low or contaminate the ambient air.Patient and user can be endangered.¿ make sure that the connected vaporizers are hanging vertically, ¿ after mounting the vaporizers, perform a leakage test.In chapter "assembly and preparation" is is said: - set the vaporizer on the plug-in adapter evenly and tightly, - turn the locking lever clockwise.The lever is in the locked position when it is pointing left, - turn the control dial to position 0; the button latches into place.Check the locking: - set the control dial on the vaporizer into another position than 0 and make sure the other vaporizer remains locked in its 0 position, - repeat the test with the other vaporizer, - set both control dials to position 0.It must be assumed that the steps listed above were not carried out correctly or sufficiently as part of the preparation prior to use on patient.Reportedly, the patient was awake and experienced discomfort from being aware during the procedure.It was 26 minutes into the case before the doctor noticed that the patient did not receive anesthetic agent.After the procedure the patient received medication (propofol, midazolam, and ativan) to assist with the ¿discomfort/experience¿.The investigation did not reveal any device malfunction.A use error not following the ifu caused the reported situation.

• 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: 24556179
• Report Number: 9611500-2026-00098
• Device Sequence Number: 15785519
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)221101(17)230228(93)MK06000-41
• 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): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown