MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

Model Number	8422500
Medical Device Problem Codes	Image Display Error/Artifact (1304); Device Difficult to Program or Calibrate (1496); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the display froze; user could not make changes.No patient health consequences have been reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
An unresponsive screen of the evita v800 was reported.The investigation of the provided logfile confirmed a temporary faulty touchscreen of the display.The deviation was obvious, deviation, the ventilation was not interrupted by that issue.It is recommended to change the ecd display bundle and test the device according to manufacturer specs.The ventilation is not affected by this issue.Field quality data are monitored and assessed by the responsible product quality board.The number of malfunctioning regarding this issue reported from the field is within accepted range.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that the display froze; user could not make changes.No patient health consequences have been reported.

• Brand Name: EVITA V800
• Common Device Name: VENTILATORS, INTENSIVE CARE
• 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: 24109022
• Report Number: 9611500-2026-00018
• Device Sequence Number: 5878803
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)241217(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222024
• 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): 02/27/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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