MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Evita V800; Anaesthesia and pulmonary Ventilation support instrument

Model Number	8422500
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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
It was reported that the screen of the device blacked out and did not reboot.Reportedly, the ventilation was continued.The device was replaced.There were no health consequences for the patient reported.
Event or Problem Description
It was reported that the screen of the device blacked out and did not reboot.Reportedly, the ventilation was continued.The device was replaced.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was based on the provided information and analysis of the device logfile.Upon this report, the device serial number has been corrected to asum-0206.It is concluded that the activation of the inrush current limitation of efuse u1506 led to a failed ecd backlight.This symptom was previously investigated, where adverse tolerances of the electronic components were found as a potential cause.The efuse is located on the pcb ecd adapter.Switching the device off an on via the main switch can restore the backlight.Replacement of the pcb ecd adapter resolved the issue.If the failure occurs during start-up, the display remains black and ventilation cannot be started.If it happens during use, the user cannot longer adapt settings, but ventilation continues as set.Safety relevant parameters remain visible on the supplemental oled display.No alarm is generated for the backlight failure.The inrush current limitation of the fuse has already been increased in order to remedy this issue.In the event of recurrence, replacement of the pcb "ecd adapter" is recommended.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: Evita V800
• Common Device Name: Anaesthesia and pulmonary Ventilation support instrument
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; +49(451)8822868
• MDR Report Key: 24516667
• Report Number: 9611500-2026-00095
• Device Sequence Number: 18273341
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222024
• 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): 08/27/2026

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: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• 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