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

Model Number	8422400
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189); Device Handling Problem (3265); Misassembled During Installation (4049)
Health Effect - Clinical Code	Respiratory Distress Syndrome of Newborns (2046)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from customer that due to the design of the ventilator it is possible to insert the inspiratory tubing into the expiratory port and vice versa between the humidity and ventilator, as the tubing and ports are the same size, making it an inherently unsafe design and at risk of future incidents.This occurred on a drager babylog vn800 ventilator in use on a baby between (b)(6) 2024, resulting in no humidified gases going to the baby during this time.In this case it led to respiratory secretions drying out and blocking the et tubes, needing x5 et tube replacements in 11 day period due to obstruction with these thick secretions, as well as regular et lavage to remove secretions.The baby possibly stayed on ventilator longer and had increased hospital stay for more days than would have been.To clear secretions requires humidity and the cilia hairs in the lining of the airway moves these upwards to be cleared.The dry gases may have affected these cilia, making it more difficult for secretions to be cleared and may have caused long term damage.Baby is now in air and has no increased work of breathing or cough and it is therefore unlikely that the lack of humidity has had a long-term effect.While there is no definite long-term damage from the period of dry oxygen exposure, we will continue to monitor for any potential effects.Therefore, this baby will require ongoing follow up by the paediatric respiratory team.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.The unique device identifier (udi) of the affected product could not be determined due to the missing serial number of the device.We will request the serial number from the customer.If this attempt leads to an udi, we will add it in our follow-up report.
Additional Manufacturer Narrative
The investigation was based on the provided information.Based on the information the breathing circuit was incorrectly assembled by the user during setup.There is no indication of a device malfunction.The inspiratory and expiratory connections meet the requirements of iso 80601-2-12 and iso 5356-1.Furthermore, the inspiratory and expiratory port are marked with arrows indicating the gas flow direction as a risk mitigation measure.The ifu includes a caution that informs the user to humidification is ineffective if the connections for inspiration and expiration are reversed." additionally, the test point two and three of the device check requires to check and confirm following: 1.Breathing circuit connection (visual inspection of breathing circuit) 2.Inspect humidifier (visual inspection of breathing gas humidifier).In case of the user reverse the gas output port and the gas return port, not noticing that the humidifier is in the expiratory limb the breathing gas humidification is ineffective which would led after a time to necrosis of airway mucosa.No device malfunction.Use error.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported from customer that due to the design of the ventilator it is possible to insert the inspiratory tubing into the expiratory port and vice versa between the humidity and ventilator, as the tubing and ports are the same size, making it an inherently unsafe design and at risk of future incidents.This occurred on a drager babylog vn800 ventilator in use on a baby between (b)(6) 2024, resulting in no humidified gases going to the baby during this time.In this case it led to respiratory secretions drying out and blocking the et tubes, needing x5 et tube replacements in 11 day period due to obstruction with these thick secretions, as well as regular et lavage to remove secretions.The baby possibly stayed on ventilator longer and had increased hospital stay for more days than would have been.To clear secretions requires humidity and the cilia hairs in the lining of the airway moves these upwards to be cleared.The dry gases may have affected these cilia, making it more difficult for secretions to be cleared and may have caused long term damage.Baby is now in air and has no increased work of breathing or cough and it is therefore unlikely that the lack of humidity has had a long-term effect.While there is no definite long-term damage from the period of dry oxygen exposure, we will continue to monitor for any potential effects.Therefore, this baby will require ongoing follow up by the paediatric respiratory team.

• 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: 21695998
• Report Number: 9611500-2025-00153
• Device Sequence Number: 15780009
• Product Code: CBK
• UDI-Device Identifier: 04048675542476
• UDI-Public: (01)04048675542476
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8422400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown