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

Model Number	8422200
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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: the customer reported an issue where the device suddenly shut down during operation while connected to a patient.The device alarmed.According to the initial log analysis, the device had stopped unexpectedly at the reported time.No pat.Health consequences have been reported.However, 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 conditions.
Event or Problem Description
The following issue was reported: the customer reported an issue where the device suddenly shut down during operation while connected to a patient.The device alarmed.According to the initial log analysis, the device had stopped unexpectedly at the reported time.No pat.Health consequences have been reported.However, 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 conditions.
Additional Manufacturer Narrative
The provided video clip and log file of the affected vn600 with product serial no.(b)(6) produced in may 2023 were investigated with respect to the reported event.Dräger onsite service replaced the printed circuit board assembly pba m48.3 upon request which resolved the issue.The part was returned for investigation to the manufacturer site in lübeck.The usd cards were not returned.The complaint investigation confirmed that babylog vn600 (b)(6) had lost functioning completely whilst ventilating and was not able booting up anymore.The malfunction was issued by activating the secondary acoustic alarm signal.Since the returned printed circuit board assembly pba m48.3 was found within specification, a potential electromechanical contact problem with the usd cards was assessed to be the most likely root cause.The device behaved and alarmed as specified.No patient health consequences have been reported.In case of a complete loss of function of the ventilator, the ventilation stops and the safety valve opens automatically to the ambient allowing the patient for spontaneous breathing.The screen turns black and the secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 20650788
• Report Number: 9611500-2024-00496
• Device Sequence Number: 6772849
• Product Code: CBK
• UDI-Device Identifier: 04048675551713
• UDI-Public: (01)04048675551713(11)230509(93)8422200-05
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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