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

Catalog Number	8422300
Medical Device Problem Codes	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	03/13/2023
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 stopped working while in use and showed a black screen.According to the user, the device gave an alarm here.No patient injury was reported.
Event or Problem Description
It was reported that the device stopped working while in use and showed a black screen.According to the user, the device gave an alarm here.No patient injury was reported.
Additional Manufacturer Narrative
The logbook and a provided video of the device were analyzed.Based on the logbook entries, it can be seen that the log recording stopped unexpectedly at 5:29 am system time on 03/13/2023 in pc-bipap ventilation mode, indicating a device failure.From the video, it was evident that the device did not start after the main power switch was turned on and the audible piezo auxiliary alarm beeped continuously.Based on the status leds, it can be seen that a faulty m48.3 circuit board is the root cause of the device behavior.The problem was solved by replacing the affected circuit board.In the event of a complete loss of function of the ventilator, the safety valve automatically opens against the environment, thus allowing the patient to breathe spontaneously.The ventilator unit's auxiliary audible alarm alerts to notify the user of the unit failure.This alarm is supplied from an independent voltage source and lasts for at least 2 minutes.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: 17142618
• Report Number: 9611500-2023-00221
• Device Sequence Number: 16621180
• Product Code: QOV
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)200916(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): 08/07/2023

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 Catalogue 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: 06/01/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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
• Patient Sex: Unknown