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); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator shut down while in use on a patient and continuously alarmed until they swapped them to a spare ventilator.No patient health consequences have been reported.
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 ventilator shut down while in use on a patient and continuously alarmed until they swapped them to a spare ventilator.No patient health consequences have been reported.
Additional Manufacturer Narrative
The evita v800 device with product serial no.(b)(6) was analyzed via provided information incl.The secured log files.According to the log, it could be identified that the error messages ¿device failure (14)¿ and the subsequent ¿alarm system failed¿ were issued at the reported time.Both alarms resulted from a temporary impairment of the internal hdbaset communication between the ecd and the ventilation unit.In such cases, display functions may be affected and the screen may turn black.In such cases, display functions may be impaired and the screen may go black.If there is an internal failure of the display unit (ecd) and/or a malfunction in the internal hdbaset communication between the ventilation unit and the ecd, the alarm message ¿unit failure (14)¿ is displayed.In this case, the screen went black but ventilation continued.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.The user may misinterpret a temporary display malfunction or black screen as a shutdown.The device reacted as specified.The system cable was recently replaced.Therefore, it is recommended to adjust this connection (between the system cable connector and the pba syscon circuit board or its seat in the pba pi main ecd circuit board) and test the device according to manufacturer specs afterwards.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: 24290263
• Report Number: 9611500-2026-00049
• Device Sequence Number: 10153722
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)201214(93)8422500-04
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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