MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG VN800; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8422400
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Complete Loss of Power (4015); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
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 during use, a sudden beeping alarm sounded, the power shut down, the screen went black, and ventilation stopped.After that, turning the power off and on only triggered the alarm sound, and the unit did not start.No patient injury was reported.
Additional Manufacturer Narrative
The provided log file and description of event indicates a faulty pba m48.3.The reported behavior could therefore be confirmed.The device reacted as specified and raised the acoustical auxiliary alarm to inform the user about the issue during the event.No patient health consequences have been reported.The pba m48.3 was replaced by the technician which solved the issue.In case of a complete loss of function of the ventilator, the safety valve automatically opens to ambient allowing the patient for spontaneous breathing.The secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.The number of comparable complaints reported from the field with respect to the determined error pattern is very low and accepted by the responsible product quality board.The results of this complaint investigation did not reveal any new or additional risks that have not yet been covered by the ventilator's risk management file.
Event or Problem Description
It was reported that during use, a sudden beeping alarm sounded, the power shut down, the screen went black, and ventilation stopped.After that, turning the power off and on only triggered the alarm sound, and the unit did not start.No patient injury was reported.

• Brand Name: BABYLOG VN800
• 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: 24385613
• Report Number: 9611500-2026-00066
• Device Sequence Number: 10504871
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)251027(93)8422400-08
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• 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