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

Catalog Number 8422500

Device Problems No Display/Image (1183); Decrease in Pressure (1490); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device shuts down and restarts randomly and displays error 14.No patient consequences reported.

Event Description

It was reported that the device shuts down and restarts randomly and dispalys error 14.No patient consequences reported.

Manufacturer Narrative

The investigation of the affected evita v800 with serial no.(b)(6)was based on the reported event and enhanced logfile analysis.Additionally, the device was examined at the manufacturer repair shop in lübeck after an on-site investigation didn't fix the deviations.Based on the results of the examination, it was determined that the device had a loose connection of the printed circuit board (pcb ecd) adapter.This caused a loss of connection of the monitor to the ventilation box.Contrary to what was reported, no reboot of the device could be detected.The ventilation was not interrupted.As a safety feature of the system, the safety software analyzes and checks the proper functioning of the device.If the safety software detects a deviation regarding the display, the system emits an acoustic alarm tone.Ventilation is not affected by a display failure and continues as set.Safety-relevant parameters such as fio2, minute volume or airway pressure are shown in the additional yellow / green oled display, where the user can see the ventilation in progress.During the previous repair on site, the eeprom data was not saved for the pcb, so that the ventilation-box could not correctly recognize the version of the display.The adapter was replaced and the device was tested according to the manufacturer's specifications without any further deviations.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The event was assessed to be not reportable in accordance to the european meddev 2.12 rev.8 and the medical device regulation (mdr 2017/745).

• Brand Name: EVITA V800
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10740553
• MDR Text Key: 214780009
• Report Number: 9611500-2020-00378
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2020
• 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