MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

Catalog Number 8422500

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that: the device shut down while in use on a patient.No patient health consequences have been reported.

Manufacturer Narrative

The log file and the flow and pressure measurement module as well as the two corresponding data cables were provided for investigation.Based on the log file it could be verified that the device preformed a synchronized restart of the ventilation unit and display unit on august 01, 2022 whilst ventilation was active.It was found that the restart was caused in specified reaction on a detected adc failure of the flow and pressure measurement module.After successful restart of the device the ventilation continued until the ventilation was set into standby mode by the user.The device posted corresponding alarms to alert the user.The hardware analysis of the flow and pressure measurement module and corresponding data cables could not reveal any deviation.As a safety feature of the device, the software analyses and verifies proper function of the device.In case of a detected failure concerning the flow and pressure measurement module the device would perform a restart to mitigate the issue and post an audible alarm to alert the user.During restart the emergency-breathing valve will open to ambient allowing for spontaneous breathing.The device reacted as specified.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 Description

It was reported that the device shut down while in use on a patient.No patient health consequences have been reported.

• Brand Name: EVITA V800
• Type of Device: 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
• MDR Report Key: 15231513
• MDR Text Key: 302969954
• Report Number: 9611500-2022-00205
• Device Sequence Number: 1
• Product Code: QOV
• Combination Product (y/n): N
• PMA/PMN Number: EUA 200143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1