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

Model Number	8422400
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Human-Device Interface Problem (2949); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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
It was reported that the touch screen of the device stopped working during use on a patient.The display locked and no changes could be made.Reportedly, the device kept ventilating the patient.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the log file analysis a complete failure of the touch screen could not be confirmed.The log file analysis revealed a slow reaction of the touch screen when the touch points were selected by the user.The ongoing ventilation was not affected by the issue.The pba ecd adapter was replaced as preventive measure.In case of a reoccurrence, it is recommended to replace the ecd display bundle.If the touch screen of the ecd is not responding to user inputs, operability of the device is limited.The ventilation is not directly affected by a malfunction of the touch screen and will be continued as set.However, due to limited operability, it may be considered necessary to continue the ventilation with another device.Based on the investigation results this case is assessed to be not reportable anymore as neither a death nor a serious deterioration in the patient's state of health occurred and this is not to be expected in the event of a recurrence.
Event or Problem Description
It was reported that the touch screen of the device stopped working during use on a patient.The display locked and no changes could be made.Reportedly, the device kept ventilating the patient.There was no health consequences for the patient reported.

• 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: 23801257
• Report Number: 9611500-2025-00689
• Device Sequence Number: 9333850
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)241009(93)8422400-06
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222207
• 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,Followup
• Report Date (Section B): 01/20/2026

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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