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

Model Number	8422200
Medical Device Problem Codes	Decrease in Pressure (1490); Failure to Deliver (2338); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device issued the alarm message "device failure 1" and performed a reboot during patient 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.
Event or Problem Description
It was reported that the device issued the alarm message "device failure 1" and performed a reboot during patient use.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The affected device was examined at the local dräger repair center and the log file was made available for further investigation.The log file confirmed that the device issued on the reported device failure alarm message.The alarm was raised in specified reaction on a pneumatic power release initiated by the hardware safety circuit.The review of the log file revealed that a very short tank overpressure signal was triggered.Based on error message in relation to the software design it could be concluded that this error entry had no relation to an actual tank overpressure and is therefore considered a temporary artefact or interference.The root cause of the short signal could not be determined.There is no indication of a permanent hardware failure.As a safety feature of the system, the safety software analyses and verifies proper function of the device.In case of a detected failure of the internal safety system, the breathing system is opened to the ambient allowing the patient to breathe spontaneously.The ventilator reacted as specified on a detected failure of the internal safety system and opened the breathing system to the ambient with accompanying alarm.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: 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: 24176276
• Report Number: 9611500-2026-00024
• Device Sequence Number: 9650080
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)240131(93)8422200-05
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/24/2026

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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