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

Model Number	8422500
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device switch off during ventilation with a loud, continuous alarm sound.No patient health consequences were reported.The system test on the previous day had been completed without any deviations.
Additional Manufacturer Narrative
The log file of the affected device was made available and analysed.The log file shows that the device generated, a 'device failure (14)' alarm and the derived ¿alarm system failed¿ alarm on the reported date of event.An interruption of ventilation due to a device malfunction could not be confirmed.The 'device failure (14)' alarm was caused by a temporarily 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.The plug connection between the system cable and pba syscon ecd must be checked and adjusted.If necessary, the system cable must be replaced.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 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: 23655515
• Report Number: 9611500-2025-00649
• Device Sequence Number: 18672864
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)210126(93)8422500-04
• 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
• Report Date (Section B): 11/26/2025

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: 8422500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2021
• 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