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 Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
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 ecd display failed during operation, and the device emitted a continuous alarm.Ventilation continued.The device was subsequently replaced.No patient injuries were reported.
Additional Manufacturer Narrative
The affected device was inspected on-site by dräger service; the circuit board pba m48.3 was identified as faulty.The affected circuit board was provided for further investigation.Examination of the affected circuit board pba m48.3 confirmed that the processor (up1) no longer boots.This internal operating voltage powers, among other things, the microprocessor system on the circuit board, which is why the malfunction led to a complete loss of function of the ventilator with an accompanying audible alarm (secondary audible alarm signal).In the event of a complete loss of function of the ventilator, the inspiratory valve automatically opens to the environment, thus allowing the patient to breathe spontaneously.The secondary audible alarm signal of the ventilator unit is activated immediately to alert the user to the device failure.This alarm is powered by an independent power source and lasts for at least 2 minutes.In this case, the affected device behaved as specified and audibly alarmed the complete loss of function.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 ecd display failed during operation, and the device emitted a continuous alarm.Ventilation continued.The device was subsequently replaced.No patient injuries were 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23377662
• Report Number: 9611500-2025-00593
• Device Sequence Number: 8815617
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)230828(93)8422300-08
• 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): 12/15/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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