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

Model Number	8422300
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Bradycardia (1751); Hypoxia (1918); Asystole (4442)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
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 at around 11 pm the ventilator had a total failure during operation and without prior notice.It was reported that the patient had suffered a hypoxic-induced bradycardia and a brief asystole.The condition was stabilized under manual ventilation.The device was replaced with an another device.
Additional Manufacturer Narrative
For the investigation, the logbook of the evita v600 device with serial number (b)(6) was analyzed.In addition, the affected device was examined in our repair workshop in lübeck.Analysis of the logbook of the affected evita v600 confirms that ventilation stopped during the reported period.The ventilator responded as specified, displayed and activated the high-priority auxiliary alarm system.Inspection of the affected device in our repair workshop in lübeck determined that the root cause was a thermal defect within the blue micro-sd card.This failure of the micro-sd card meant that the microprocessor system on which the ventilation control is executed could no longer function.In the event of a complete loss of ventilation function during use, the safety valve automatically opens to the environment, allowing the patient to breathe spontaneously.The ventilation unit's audible auxiliary alarm 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.This alarm is supplied by an independent power source and lasts for at least 2 minutes.The blue micro-sd card has already been replaced at the repair workshop in lübeck, and a device check has been successfully carried out in accordance with the manufacturer's specifications.The field quality data is monitored and evaluated by the responsible product quality board.The results of this investigation did not reveal any new risks that are not covered by the product risk management file.
Event or Problem Description
It was reported that at around 11 pm the ventilator had a total failure during operation and without prior notice.It was reported that the patient had suffered a hypoxic-induced bradycardia and a brief asystole.The condition was stabilized under manual ventilation.The device was replaced with an another device.

• 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: 22456228
• Report Number: 9611500-2025-00365
• Device Sequence Number: 18181646
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)200826(93)8422300-04
• 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,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Initial
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• 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.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown