MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA V500; VENTILATOR

Model Number	8416000
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was based on the reported event and log analysis.Additionally, the device was examined by dräger service onsite.The complained display function could be reproduced.The root cause was a faulty inverter board which caused a faulty display illumination.The ventilation unit is not affected by the faults.In case of a defective display, the ventilation is not affected by the fault and is continued with unchanged settings.Safety-relevant parameters such as fio2, minute volume, or airway pressure are displayed in the secondary oled display of the ventilator and the user can observe the ongoing ventilation.The usage of the cockpit might be restricted due to limited visibility of the images.The lc display and the inverter board have been replaced by dräger onsite service and the device tested successfully according to manufacturer specs.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the display image turned off during ventilation.Device continued ventilating despite no image on display.No injury was reported.

• Brand Name: V500
• Common Device Name: VENTILATOR
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 23049494
• Report Number: 9611500-2025-00520
• Device Sequence Number: 18519722
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)201208(93)8416400-21
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093633
• 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
• Report Date (Section B): 09/15/2025

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: 8416000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 12/08/2020
• 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