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

Model Number	8422500
Medical Device Problem Codes	Image Display Error/Artifact (1304); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen turned off momentarily on a patient while the unit was still ventilating.Discussio with an rt.He said : the screen was black for probably more than 1 minute and came back by itself.No harm to the patient.He tested the unit several time after and no other issue showed up.In case the user cannot adapt ventilation parameters due to a device malfunction for a prolonged time, a serious injury cannot be excluded for patients with a serious condition.
Additional Manufacturer Narrative
The investigation was based on the reported event and logfile review of the affected device.The log file did not reveal a failure of the ecd.The technician onsite could not duplicate the reported device behavior.The device was successfully tested according to manufacturer specifications.However, it is likely that the backlight of the display unit was temporary not functioning.In the event of recurrence, replacement of the pcb ecd adapter may be considered.In case the backlight of the display unit fails during use the user is no longer able to operate the device, but 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 number of malfunctioning regarding this issue reported from the field is within accepted range.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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: 25078177
• Report Number: 9611500-2026-00190
• Device Sequence Number: 13435656
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)250919(93)8422500-10
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/05/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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