MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG VN600; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8422200
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the touch screen of the device was not functioning during use.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• Brand Name: BABYLOG VN600
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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: 25150808
• Report Number: 9611500-2026-00213
• Device Sequence Number: 13099298
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)250228(93)8422200-05
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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): 05/12/2026

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: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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