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

Model Number	8422300
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/22/2025
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 alarmed for a device failure during use, the piezo alarm was generated, and the ventilation stopped.The device was replaced and the patient was manually ventilated.There was no serious injury reported.
Event or Problem Description
It was reported that the device alarmed for a device failure during use, the piezo alarm was generated, and the ventilation stopped.The device was replaced and the patient was manually ventilated.There was no serious injury reported.
Additional Manufacturer Narrative
The affected device was examined onsite by dräger service and the log file was made available for further investigation at the manufacturer¿s site.In addition, the pba m48.3 and the microsd cards were returned for a hardware analysis.The log file shows on the reported date of event, that the device performed several reboot attempts before the reboot was successful and ventilation was continued.Some seconds after the ventilation was resumed, the device was switched into the standby mode by the user and finally switched off.The hardware investigation of the affected pba m48.3 and microsd cards did not show a permanent issue but indicated a temporary deviation regarding the ram of the microprocessor as root cause of the event.The device reacted as specified and raised the acoustic auxiliary alarm to inform the user about the malfunction.In case of a complete loss of function of the ventilator, the ventilation stops, and the safety valve opens to ambient allowing the patient to breathe spontaneously.The secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.An alternative device needs to be used to continue the 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; 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: 21760154
• Report Number: 9611500-2025-00174
• Device Sequence Number: 8455764
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)210819(93)8422300-05
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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