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

Model Number	8422400
Medical Device Problem Codes	Failure to Deliver (2338); Output Problem (3005)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shutdown intermittently.No injury reported.
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follo-up report.
Additional Manufacturer Narrative
The investigation was based on the reported event and logfile analysis of the affected babylog vn800 device.Additionally, the device was serviced via dräger technician onsite.It was reported that the system cable between the display and the ventilation unit was not routed properly.The root cause of the reported event did not correspond with a device malfunction but with an improperly routed system cable on site.It was reported that the display was mounted on the top of the bed and the ventilation unit was mounted on a ge warmer in this specific installation in this hospital.It was reported that no patient was involved.Therefore the event was assessed to be not reportable in accordance to the european meddev 2.12 rev.8 and the medical device regulation (mdr 2017/745).The dräger technician repositioned the system cable to prevent a further disconnection between display and ventilation unit.The results of this investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that the device shutdown intermittently.No injury 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: 19318472
• Report Number: 9611500-2024-00210
• Device Sequence Number: 18036727
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476(11)210310(93)8422400-03
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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
• Device Catalogue 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: 04/15/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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