MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE

Model Number	8422300
Medical Device Problem Codes	Gas Output Problem (1266); Mechanical Problem (1384); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 the device displayed a "device failure" during operation.Ventilation was no longer possible.No health consequences for the patient were reported.
Event or Problem Description
It was reported that the device displayed a "device failure" during operation.Ventilation was no longer possible.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the analysis of the log file, it could be confirmed that the safety software of the device detected implausible expiratory and inspiratory pressure readings at 07:42 pm on the reported date of event.The device then issued the alarm message "device failure" as specified and performed a pressure release.At 07:46 pm, the device was switched to standby mode by the user.In addition, the log file analysis showed a calibration error, which was triggered by an incorrectly switching solenoid valve on the calibration unit or a faulty pressure sensor.Both parts should be replaced to resolve the problem.As a safety feature of the system, the safety software analyses and checks the proper functioning of the device.If the safety software detects a deviation in the pressure measurement system, the emergency ventilation valve opens to the environment to allow spontaneous breathing.Audible alarms would inform the user of the problem.However, manual ventilation with an alternative device may be deemed necessary.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 V600
• 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: 23690341
• Report Number: 9611500-2025-00665
• Device Sequence Number: 10231642
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)220826(93)8422300-05
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 8422300
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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
• Patient Sex: Unknown