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	10/03/2025
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 during ventilation of an intubated patient, the device screen suddenly turned off without stopping ventilation.Access to settings and alarm display was no longer possible.There were no patient health consequences reported.
Event or Problem Description
It was reported that during ventilation of an intubated patient, the device screen suddenly turned off without stopping ventilation.Access to settings and alarm display was no longer possible.There were no patient health consequences reported.
Additional Manufacturer Narrative
The affected device was examined onsite by technician and the log file was made available for further investigation.Based on the device examination, a temporary disruption of the electromechanical contact between the display unit (ecd) and the ventilation unit was identified as root cause of the reported event.After reseating the pba syscon ecd, the device was successfully tested according to the manufacturer¿s specification.Basded on the log file analysis, the issue could be confirmed as the log file shows the 'device failure (14)' alarm.In case of an impaired internal hdbaset communication between the ventilation unit and the ecd the alarm message 'device failure (14)' will be raised.The ventilation will be not affected and continued as set.The display functions and operability of the ecd might be affected in case of an active 'device failure (14)' alarm event depending on then technical root cause.The user may misinterpret a temporary display malfunction or black screen as a shutdown.If the internal hdbaset communication fails completely, the secondary alarm (piezo speaker) of the ventilation unit will sound.Safety relevant parameters as fio2, minute volume and airway pressure are displayed on the supplemental oled-display wherein the user can observe the ongoing ventilation.In the current event, the device reacted as specified to a detected internal deviation and generated the corrersponding alarm message.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: 23401425
• Report Number: 9611500-2025-00601
• Device Sequence Number: 18687014
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)210826(93)8422500-05
• Combination Product (Y/N): N
• Initial Reporter Country: FG
• 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,Followup
• Report Date (Section B): 11/28/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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