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

Model Number	8422300
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
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 a failure occurred during use.The display of the device went black, and a continuous audible alarm sounded.The alarm could not be paused or cancelled and could only be stopped by switching off the device at the main switch.No health consequences for the patient were reported.
Event or Problem Description
It was reported that a failure occurred during use.The display of the device went black, and a continuous audible alarm sounded.The alarm could not be paused or cancelled and could only be stopped by switching off the device at the main switch.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.The analysis of the log file could confirm a "device failure (14)" and derived "speaker faulty" alarm event.Both alarms were caused by a temporary impaired internal hdbaset communication between the display unit (ecd) and the ventilation unit.This symptom is characteristic for a temporary disruption of the electromechanical contact between the system cable and pba syscon ecd or a faulty system cable.In this failure mode the display functions might be impaired and/or the screen turns black.The system cable was already replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturer´s specification.In case of an impaired internal hdbaset communication between the ventilation unit and the ecd the alarm message "device failure (14)" will be raised.The ventilation will be not affected and continued as set.The display functions and operability of the ecd might be affected in case of an active "device failure (14)" alarm event depending on then technical root cause.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 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22791869
• Report Number: 9611500-2025-00446
• Device Sequence Number: 8789498
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)200527(93)8422300-04
• 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): 09/11/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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