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 Deliver (2338); Reset Problem (3019)

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

Event Date 06/04/2022

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 unit restarted on a patient.No patient harm was reported.

Manufacturer Narrative

The log file of the affected device was analysed for investigation.Based on the log file an unexpected, synchronized restart of the ventilation unit and the display unit on the date of event could be confirmed.The restart was initiated in reaction to a ram memory corruption.The printed circuit board used as the central processing unit to control and monitor the device was replaced and send in for detailed examination.The replaced part was undergoing a functional test and ram memory stress test as well as an endurance test in an independent laboratory ventilator for 29 days.These tests revealed no deviation from the specification.A restart of the device could not be reproduced during the endurance test.Consequently, the root cause of the identified ram memory corruption could not be conclusively clarified.The device reacted as specified on detecting a ram memory corruption by triggering a synchronized restart of the ventilation unit and the display unit in order to reset the system to a specified state.During restart sequence, the ventilation is temporarily interrupted, and the safety valve is opened to the ambient allowing the patient to breathe spontaneously.The device alerted the situation as intended and resumed the ventilation after restarting with the last settings.In this case no patient consequences were reported.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 unit restarted on a patient.No patient harm was 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: 14754021
• MDR Text Key: 297538630
• Report Number: 9611500-2022-00151
• Device Sequence Number: 1
• Product Code: QOV
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)200331(93)8422500-08
• Combination Product (y/n): N
• PMA/PMN Number: EAU200143
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2020
• 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