MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Babylog VN800; Anaesthesia and pulmonary Ventilation support instrument

Model Number	8422400
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
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 customer states unit shut off with high pitched alarm while on a patient.No patient harm.
Event or Problem Description
It was reported that customer states unit shut off with high pitched alarm while on a patient.No patient harm.
Additional Manufacturer Narrative
The reported event could be confirmed according to the analysis of the logfile at the manufacturer site and onsite examination of the affected device by dräger service technician.Root cause was a faulty pba m48.3.The device reacted like specified and raised the acoustical auxiliary alarm to inform the user about the issue.The pba m48.3 and the sd cards were replaced by the technician which solved the issue.Afterwards the device was tested and confirmed to be operating by manufacturer's specifications.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 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 product quality board responsible.The results of this investigation of this complaint did not reveal any new or additional risks that have not yet been covered by the ventilator's risk management file.

• Brand Name: Babylog VN800
• 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 ; +49(451)8822868
• MDR Report Key: 23678879
• Report Number: 9611500-2025-00662
• Device Sequence Number: 15698748
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/17/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown