MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG VN800; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422400
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
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
The following was reported: screen went blank - came back up - then touch screen froze up date/time: on (b)(6) 2025: time unknown; during the night.Swapped vent to resolve.No adverse patient effect.
Additional Manufacturer Narrative
The investigation of the provided information incl log analysis revealed that the reported blank and froze up screen was triggered by a plugged in usb stick at the reported time.In the ifu, some usb devices are excluded from the list as they can lead to an impairment of functionality when connected to the device.However, some visual screen malfunctions are obvious to the user.The ventilation was not interrupted by the issue and continued as set.The running ventilation is not affected by cockpit failure like reboot, no boot, red tint, black screen or flickering screen and affects only the display.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display and the user can see the on-going ventilation.The investigation indicated no technical malfunction of the device.Onsite a dräger service technician tested the device according to manufacturer¿s specifications with any issues.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
The following was reported: screen went blank - came back up - then touch screen froze up date/time: (b)(6) 2025/time unknown during the night.Swapped vent to resolve.No adverse patient effect.

• Brand Name: BABYLOG VN800
• 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: 24091610
• Report Number: 9611500-2026-00015
• Device Sequence Number: 10259041
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)251017(93)8422400-08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222207
• 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): 02/16/2026

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: 8422400
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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