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

Model Number	8422200
Medical Device Problem Codes	Failure to Read Input Signal (1581); Failure to Deliver (2338); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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
The following issue was reported: problem of "device failure 02" arises while continue running of ventilator more than two days.Before and after of this error, system test is successful always.Once we restart the ventilator, no device failure is there but comes again within 2- or 3-days continuous ventilation.We have observed this device failure 3 times.No patient health consequences have been reported.
Additional Manufacturer Narrative
The investigation was based on the reported event and log analysis.The requested pba m48.3 was requested for investigation but did not arrived in lübeck.The analysis of the provided log file revealed that babylog vn600 detected an issue with the reset logic on several timestamps and performed several restarts.Furthermore, the alarm message "device failure (2)" and "ventilation unit restarted" were raised several times.As per log file the ventilation continued after successful restart.The log file entries indicate a hardware issue of the pba m48.3.The device reacted and alarmed as specified.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation.In this case, no patient health consequnces have been reported.If not yet done replace pba m48.3 and test the device as per manufacturer specifications.The number of comparable complaints reported from the field with respect to the determined error pattern is very low and accepted by the responsible product quality board.The results of this complaint investigation did not reveal any new or additional risks that have not yet been covered by the ventilator's risk management file.
Event or Problem Description
The following issue was reported: problem of "device failure 02" arises while continue running of ventilator more than two days.Before and after of this error, system test is successful always.Once we restart the ventilator, no device failure is there but comes again within 2- or 3-days continuous ventilation.We have observed this device failure 3 times.No patient health consequences have been 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: 22148709
• Report Number: 9611500-2025-00288
• Device Sequence Number: 15406783
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)220128(93)8422200-03
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/31/2025

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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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
• Patient Sex: Unknown