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

Model Number	8422300
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
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's screen failed during treatment of a patient with o2 therapy, causing the piezo alarm to be triggered.Ventilation continued and the patient's vital parameters were not affected.The device was subsequently replaced by the user.
Additional Manufacturer Narrative
The affected device was checked by dräger service and the logbook was available for analysis by the manufacturer.The logbook entries from october 19th show that the device was functioning properly until 7:10 p.M.At that time, the device was switched off by pressing the main switch and was not restarted that day.During the device test, a temporary screen failure was detected during a test ventilation, after which the device could not be restarted successfully.After the device was dismantled to identify the problem, the error could not be reproduced.The logbook entries do not indicate a permanent hardware malfunction that leads to the screen failure.Based on the device analysis and the log entries, the cause of the screen failure cannot be clearly identified.However, the problems when starting the device during the device test are due to a deviation on the m48 circuit board.Replacing the circuit board solves the problem.If the screen stops working, ventilation continues with the last settings.Safety-relevant parameters such as fio2, minute volumes or airway pressure, as well as an indicator for ongoing ventilation are shown in the additional oled display on the ventilation unit.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device's screen failed during treatment of a patient with o2 therapy, causing the piezo alarm to be triggered.Ventilation continued and the patient's vital parameters were not affected.The device was subsequently replaced by the user.

• 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: 20639100
• Report Number: 9611500-2024-00491
• Device Sequence Number: 20705128
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)210202(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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown