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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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 had a black screen during operation when switching from cpap to bipap.The device was replaced immediately by the user.No patient injury was reported.
Additional Manufacturer Narrative
The logbook of the affected device was examined for the reported event.Based on the analysis of the logbook, a "device error (14)" alarm was confirmed.The alarm was caused by a temporarily disturbed internal hdbaset communication between the ecd and the ventilator.This symptom is characteristic of a temporary interruption of the electromechanical contact between the system cable and the pba syscon ecd or a faulty system cable.In this error mode, the display functions may be impaired or the screen may be completely black.The device was repaired by checking and adjusting the connector and replacing the system cable.In the event of an internal error of the display unit (ecd) and a disturbed internal hdbaset communication between the ventilator and the ecd, the alarm message "device error (14)" is triggered.The display functions and the operability of the ecd may be impaired in the event of an active alarm event "device error (14)" depending on the technical cause.If the internal hdbaset communication fails completely, the ventilator's secondary alarm (piezo loudspeaker) sounds.Safety-relevant parameters such as fio2, minute volume and airway pressure are shown on the additional oled display, on which the user can observe the ongoing ventilation.In this case, the device behaved as specified for the error.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device had a black screen during operation when switching from cpap to bipap.The device was replaced immediately by the user.No patient injury was reported.

• 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: 21176436
• Report Number: 9611500-2025-00037
• Device Sequence Number: 17215126
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)210127(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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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