MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLOG VN600; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8422200
Medical Device Problem Codes	No Display/Image (1183); Human-Device Interface Problem (2949); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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 device turned off while connected to a patient.No patient injury was reported.
Additional Manufacturer Narrative
The affected device was tested by dräger service and the log file of the affected device was provided for the initial evaluation.The analysis of the log file revealed that the device posted the alarm messages "device failure 1", "device failure 2", "device failure 11" and "device failure 14" during the event.Testing of the device found a blown fuse.The affected hardware was replaced and provided for further analysis.The analysis of the provided hardware revealed a short circuit of the pba pi main ecd.As a consequence, the fuse f5 placed on the pba pi power iii was blown.The fuse f5 protect among others the power supply of the screen.As a result of the blown fuse the screen failed and became dark.Additionally, as the essential operating voltages could not be provided, several device failure alarms were generated by the device.The affected pba pi power iii and pba pi main ecd were replaced to resolve the issue.Based on the investigation results the ventilation was not affected and continued as set while the display was dark.The device reacted like specified and posted accompanying alarm message as a result of a detected deviation.Safety relevant parameters as fio2, minute volume, or airway pressure as well as an indicator for the ongoing ventilation are displayed in the supplemental yellow/green oled-display located on the ventilation unit.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 turned off while connected to a patient.No patient injury was reported.

• Brand Name: BABYLOG VN600
• 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: 21983398
• Report Number: 9611500-2025-00232
• Device Sequence Number: 8312962
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)240214(93)8422200-05
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 8422200
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown