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

Model Number	8422400
Medical Device Problem Codes	Degraded (1153); 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	03/27/2025
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 panel does not work and cannot be operated at all.Turning off was attempted but failed.There was no health consequences for the patient reported.
Additional Manufacturer Narrative
The display of the affected device was provided for the investigation.The hardware analysis could confirm the reported situation.The issue revealed to a temporary faulty touchscreen system.It was recommended to replace the ecd display bundle vn800 and testing the device accorrding to manufacturer specs afterwards.The fact that the operation of the display¿s touchscreen is partly impaired several settings cannot changed by the customer.A running ventilation is not affected by the reported failure of the touchscreen.However, in case the user cannot adapt ventilation parameters due to a device malfunction for a prolonged time, a serious injury cannot be excluded for patients with a serious condition.In this case, no patient health consequences have been reported.Field quality data are monitored and assessed by responsible product quality board.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 touch panel does not work and cannot be operated at all.Turning off was attempted but failed.There were 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21897985
• Report Number: 9611500-2025-00212
• Device Sequence Number: 11621656
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)240610(93)8422400-06
• Combination Product (Y/N): N
• PMA/510(K) Number: EUA201036
• 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): 06/02/2025

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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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
• Patient Sex: Unknown