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

Model Number	8422400
Medical Device Problem Codes	Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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 the screen of the device went black, and the ventilation stopped during use.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The affected device was inspected on site by dräger service and the circuit board pba m48.3 was identified as faulty.The affected circuit board was made available for further investigation.Other than initially reported, the affected device is the babylog vn800, serial no.(b)(6).The investigation confirmed that the device had completely lost its function due to a persistent component failure on printed board assembly pba m48.3.Hardware analysis showed that the internal voltage supply had failed and the printed circuit board pba m48.3 was getting inoperable resulting to a complete loss of function of the ventilator.In case of a complete loss of function of the ventilator, the ventilation stops and the safety valve opens automatically to the ambient allowing the patient for spontaneous breathing.The screen turns black and the secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated in order 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 similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the screen of the device went black, and the ventilation stopped during use.There were no health consequences for the patient reported.

• Brand Name: BABYLOG VN800
• Common Device Name: VENTILATORS, INTENSIVE CARE
• 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: 23406225
• Report Number: 9611500-2025-00605
• Device Sequence Number: 4940739
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)240209(93)8422400-06
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093633
• 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): 12/10/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Patient Sex: Unknown