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

Model Number	8422400
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	11/29/2024
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 device issued a device failure alarm during use.The device shut down.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was based on the reported event and log analysis of the affected vn800 device with product serial no.(b)(6).The log file confirmed that the ventilator issued an correct alarm at the reported time.This 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 alarm message in relation to the software design it could be concluded that this entry had no relation to an actual tank overpressure and is therefore considered a temporary artefact or interference.There is no indication of a permanent hardware failure.The ventilator reacted as specified on a detected deviation of the internal safety system and opened the breathing system to the ambient with accompanying alarm.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.Another ventilator shall be used to continue ventilation.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 device issued a device failure alarm during use.The device shut down.There were no health consequences for the patient 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: 20966547
• Report Number: 9611500-2024-00587
• Device Sequence Number: 4121487
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)240126(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): 11/20/2025

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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