MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Evita V800; Ventilators, Intensive Care

Model Number	8422500
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device restarted whilst in use on a patient.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• 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 ; +49(451)8822868
• MDR Report Key: 50930258
• Report Number: 9611500-2026-00492
• Device Sequence Number: 13152464
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)220519(93)8422500-05
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/29/2026

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?: No
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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.
• Patient Sex: Unknown