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

Model Number	MK06000
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Sensing Intermittently (1558); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided within a separate follow-up-report.
Event or Problem Description
It was reported that the ventilator failed during use.There was n injury.
Event or Problem Description
It was reported that the ventilator failed during use.There was an injury.
Additional Manufacturer Narrative
The electronic device logfile was analysed regarding hints for a possible malfunction of the device.The reported symptom was verified during the logfile analysis.An inadequately secured tie rod subsequently caused a loose connection at the interface between the flow sensor and the associated cable harness.The failure of inspiratory flow measurement led to a temporary failure of volume-controlled ventilation.Pressure-controlled ventilation was not affected.However, the mechanical play between the breathing system and the interface caused limitations in pressure/peep control.The device issued appropriate alarms.All alarms, possible causes as well as remedies are described in the instructions for use.The tie rod was tightened and the device has been returned to use.The number of similar cases, related to the same root cause, 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: 24909216
• Report Number: 9611500-2026-00157
• Device Sequence Number: 18440712
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)191120(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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown