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

Model Number	8422300
Medical Device Problem Codes	Decrease in Pressure (1490); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen of the device froze and then the device turned off during use on a patient.As a result, the device was replaced.There was no patient injury reported.
Additional Manufacturer Narrative
The log file was of the affected device was provided to the manufacturer for a detailed analysis.The logged entries show that the safety software of the device detected a significant difference in expiratory and inspiratory pressure on the reported date of event april 2nd at 2:32 am as well as on the previous day at 4:46 am.As a result, the alarm message "device failure" was posted by the device and the ventilation unit performed a pressure release.Furthermore, the ventilation related alarm messages "airway pressure low" and "tidal volume high" were posted and suction maneuvers were performed around the reported time stamps.There is no indication of a technical malfunction in the log file.The initially reported frozen screen and device shutdown could not be confirmed based on the available information.Based on the results of the investigation it is likely that the root cause of the event was an issue within the breathing circuit or a suction during ventilation.The device reacted as specified to a significant difference in expiratory and inspiratory pressure with accompanying visual and audible alarm messages.A pressure release of the pneumatic system as a safety measure was performed to allow for spontaneous breathing.However, manual ventilation with an alternate device may be considered 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22157163
• Report Number: 9611500-2025-00292
• Device Sequence Number: 15663865
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)201103(93)8422300-04
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/06/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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.
• Patient Sex: Unknown