MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Perseus A500; Anesthesia Units

Model Number	MK06000
Medical Device Problem Codes	Gas Output Problem (1266); Unexpected Therapeutic Results (1631); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed obvious signs of a significant desaturation (cyanosis) whereupon the users noticed that the anesthesia workstation was in standby and not ventilating.As per report, ventilation support was bridged manually until a system test was passed successfully and ventilation could be started.The desaturation was reportedly removed quickly after re-establishing ventilation, preventing from final health consequences.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up/final report.

• 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 ; +49(451)8822868
• MDR Report Key: 50171526
• Report Number: 9611500-2026-00409
• Device Sequence Number: 9886704
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)220715(17)220928(93)MK06000-41
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/07/2026

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
• Initial Date Received by Manufacturer: 08/01/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown