MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 800; VENTILATORS, INTENSIVE CARE

Catalog Number 8422500

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the screen of the device repeatedly goes black.No patient injury was reported.

Manufacturer Narrative

The investigation was based on the log file and the analysis of the affected hardware components.The reported device behaviour could be reproduced.The hardware analysis revealed that the activation of the inrush current limitation of the fuse on the printed circuit board of the lc display led to a dark backlight of the lc display.The activation of this fuse was traced back to adverse tolerances tolerance of the electronic components on the adapter board of the display unit of the device.In case this fuse is activated, the display unit boots up, but the graphic elements on the display are only partially visible due to the failure of the back light.The operation of the ventilator by the user is limited due to the hardly visible graphics.However, any active ventilation would not be affected by this issue.The inrush current limitation of the fuse has already been increased in oder to remedy this issue.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 screen of the device repeatedly goes black.No patient injury was reported.

• Brand Name: EVITA 800
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16361550
• MDR Text Key: 309376700
• Report Number: 9611500-2023-00058
• Device Sequence Number: 1
• Product Code: QOV
• Combination Product (y/n): N
• PMA/PMN Number: EUA200143
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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