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

Model Number	8422400
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
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 ventilator shut down during use and could not be restarted.It was reported that no patient injury occurred.At the time of the incident, the device was connected to the mains power and the battery was charging.
Event or Problem Description
It was reported that the ventilator shut down during use and could not be restarted.It was reported that no patient injury occurred.At the time of the incident, the device was connected to the mains power and the battery was charging.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the log file analysis the reported device shut down could not be confirmed.The log file analysis revealed a "device failure (14)" and derived "alarm system failed" alarm event.Both alarms were caused by a temporary impaired internal hdbaset communication between the display unit (ecd) and the ventilation unit.As a result, the user turned off the device via the rocker switch.The impaired communication is characteristic for a temporary disruption of the electromechanical contact between the system cable and pba syscon ecd or a faulty system cable.The system cable and pba syscon ecd need to be checked for proper fitment and to be reseated if necessary.In case of recurrence the system cable should be replaced.In case of an impaired internal hdbaset communication between the ventilation unit and the ecd the alarm message "device failure (14)" will be raised.The ventilation will be not affected and continued as set.The display functions and operability of the ecd might be affected in case of an active "device failure (14)" alarm event depending on then technical root cause.If the internal hdbaset communication fails completely, the secondary alarm (piezo speaker) of the ventilation unit will sound.Safety relevant parameters as fio2, minute volume and airway pressure are displayed on the supplemental oled-display wherein the user can observe the ongoing ventilation.Based on the investigation results, we do not consider the case to be reportable anymore, as neither a death nor a serious deterioration in the patient's state of health occurred and this is not to be expected in the event of a recurrence.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22641058
• Report Number: 9611500-2025-00417
• Device Sequence Number: 5418996
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)220328(93)8422400-04
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EUA201036
• 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): 10/13/2025

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): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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