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

Model Number	8422400
Medical Device Problem Codes	Loss of Data (2903); No Apparent Adverse Event (3189); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that machine had data loss message and then shut down while in use.No patient injury was reported.
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Additional Manufacturer Narrative
The affected device was analyzed by dräger service and the log file was secured for further evaluation.Based on the log entries it can be confirmed that the device alarmed ¿data loss¿ as a result of a detected internal data persistency issue on (b)(6) 2024 at 1:42 am (device system time).However, there is no indication of an unexpected device shutdown due to a technical failure.The user switched of the device a few minutes later via user interaction at 2:01 am.During the device analysis the pba m48.3 as well as three usd cards were identified as possible causes and were replaced to resolve the issue.After replacement, the device was fully functional again and passed all tests.Further analysis of replaced parts at the manufacturer revealed that the red usd card was non-functional, and the two others showed errors in the file system.The pba m48.3 passed all functional tests without deviation.In case current ventilation settings cannot be saved into the persistency on the red usd card, the ventilator will prompt the alarm message "data loss" but continues ventilation with current settings.In this failure mode, those settings cannot be restored upon next start of the device.In this failure mode it shall be considered using another device 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.Based on the investigation results this case is not considered reportable anymore as the device did not cause or contribute to a death or serious injury and would not result in a serious injury if the malfunction were to recur.
Event or Problem Description
It was reported that machine had data loss message and then shut down while in use.No patient injury was 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 19612415
• Report Number: 9611500-2024-00267
• Device Sequence Number: 20382799
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)240307(93)8422400
• Combination Product (Y/N): N
• 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): 03/04/2025

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: 05/30/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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