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

Model Number	8422400
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results will be provided in the final report.
Event or Problem Description
It was reported that the unit shut off while in use.No reported patient injury.
Event or Problem Description
It was reported that the unit shut off while in use.No reported patient injury.
Additional Manufacturer Narrative
The investigation was based on the reported event incl.Provided information from service technician onsite and log analysis.Additionally, the exchanged material pba m48 and the sd card were examined at the manufacturer site in lübeck.The investigation of the provided log file confirmed a restart of the ventilation unit at the reported time.The device alarmed and behaved as specified due to a temporary deviation of pba m48.The replaced parts had shown no malfunction.The result of the investigation indicates that the restart of the ventilation unit occurred due to a temporary issue.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a restart of the ventilation unit will be triggered with accompanying alarm.The restart sequence lasts for a maximum of 8 seconds.During that time the emergency-breathing valve remains open to ambient allowing for spontaneous breathing.After successful restart the ventilation will be automatically resumed and continued with the latest settings.The parts were replaced and the device was tested according to manufacturer¿s specifications; all tests passed with no issues.The number of temporary malfunctions of the m48 reported from the field is within accepted range assessed by the responsible product quality board and is accepted.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• Brand Name: BABYLOG VN800
• Common Device Name: ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMEN
• 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: 22326779
• Report Number: 9611500-2025-00333
• Device Sequence Number: 20905158
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)240415(93)8422400-06
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/09/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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