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

Model Number	8422500
Medical Device Problem Codes	No Display/Image (1183); Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported where a v800 ventilator display turned off on a patient during ventilation.The patient on the ventilator continued to receive breaths and patient was not harmed.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The log file of the affected device was provided for the investigation.The analysis of the log file could confirm that the device performed a restart on the reported date of event.The device restart was caused by a potential temporary malfunction of pba m48.3.The pba m48.3 and the micro sd card were requested for further investigation but have not been provide.As a result, the underlying root cause could not be clarified.As a safety feature of the system, the safety software analyses and verifies proper function of the device.In case of a detected deviation regarding operation of the ventilation unit, the safety software triggers a synchronized restart of the ventilation unit and the display unit (ecd) in order to reset the system to a specified state.During restart sequence the ventilation is temporarily interrupted, and the inspiratory valve is opened to ambient allowing the patient for spontaneous breathing.The deviation will be indicated by activated auxiliary auditory alarm.Single restart sequence of the ventilation unit takes up to 8 seconds until evita v800 automatically resumes the ventilation with the latest settings.The restart sequence of the ecd may take up to a maximum of 1 minute.In the meantime, the user can observe the already resumed ventilation and safety-relevant parameters such as fio2 concentration, minute volume and airway pressure in the oled-display of the ventilation unit.Finally, the alarm message "ventilation unit restarted" will be prompted on the screen with accompanying auditory alarm and the auxiliary auditory alarm ceases automatically.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 where a v800 ventilator display turned off on a patient during ventilation.The patient on the ventilator continued to receive breaths and patient was not harmed.

• 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: 22641056
• Report Number: 9611500-2025-00416
• Device Sequence Number: 5418995
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)231006(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/06/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown