MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422500
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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 device issued a temperature alarm before the device turned itself off.The device was replaced.No health consequences for the patient were reported.

• Brand Name: EVITA V800
• Common Device Name: ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT
• 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: 24726264
• Report Number: 9611500-2026-00133
• Device Sequence Number: 10265574
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)251202(93)8422500-10
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 8422500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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