MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG VN600; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422200
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the display of the device shut down during operation.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service.The log file was secured for further investigation.The investigation confirmed that the display unit was not functioning.A faulty ecd adapter ii was identified as root cause.The faulty ecd adapter ii was replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturers specification.In case the display unit fails during use the user is no longer able to operate the device.The running ventilation is not affected and will be continued as set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display wherein the user can see the on-going ventilation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: BABYLOG VN600
• 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: 24923796
• Report Number: 9611500-2026-00161
• Device Sequence Number: 16019345
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)230505(93)8422200-05
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 8422200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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