MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

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	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shut down during patient use.Reportedly, the piezo alarm kept sounding and the screen remained completely black.It is presumed that the ventilation had stopped.There was no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was based on the log file of the affected device.Based on the log file analysis the reported device shutdown and stop of ventilation could not be confirmed.The analysis of the log file identified a failure of the blacklight of the display.The hardware analysis of previous complaints revealed that the activation of the inrush current limitation of the fuse on the printed circuit board of the lc display led to a dark backlight of the lc display.The activation of this fuse was traced back to adverse tolerances of the assembled electronic components on the adapter board of the display unit of the device (ecd).In case the backlight of the display unit fails during use, the user is no longer able to operate the device.The running ventilation is not affected and will be continued as set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental yellow/green oled-display wherein the user can see the on-going ventilation.The inrush current limitation of the fuse has already been increased in order to remedy this issue.The symptom can be resolved by switching off and on the device via the main switch.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: VENTILATORS, INTENSIVE CARE
• 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 ; 4518822868
• MDR Report Key: 23401432
• Report Number: 9611500-2025-00598
• Device Sequence Number: 10179931
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)210125(93)8422500-04
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 8422500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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