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

Model Number	8422500
Medical Device Problem Codes	Gas Output Problem (1266); No Device Output (1435); Failure to Deliver (2338); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device stopped working during use.A disconnection/leakage was detected while a patient was connected.The self-test was incomplete.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.
Event or Problem Description
It was reported that the device stopped working during use.A disconnection/leakage was detected while a patient was connected.The self-test was incomplete.No health consequences for the patient were reported.
Additional Manufacturer Narrative
For the investigation, the information provided, including a photo of a test of the device and the affected eva v800's logbook, was analyzed.The logbook indicated that the reported incident was attributable to a faulty lpsv (low pressure safety valve).The failure of the lpsv was indicated to the user by accompanying audible and visual alarms on the device.A subsequent self-test performed by the user failed.As a safety feature of the system, the safety software analyzes and verifies the proper functioning of the device.In the event of a deviation in the gas dosing and mixing module, the gas supply is interrupted and the emergency breathing valve opens to the environment to allow spontaneous breathing.Audible and visual alarms are triggered to inform the user of the problem.The device behaved as specified.The affected component must be replaced, and the device must be tested according to the manufacturer¿s specifications before being put back into service.The number of similar cases reported from the field is very low and falls within the range monitored and accepted by the responsible product quality board.The investigation of the complaint did not reveal any new or additional risks beyond those already addressed in the device¿s 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: 24586258
• Report Number: 9611500-2026-00103
• Device Sequence Number: 5597461
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148
• 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,Followup
• Report Date (Section B): 04/24/2026

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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown