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); No Flow (2991); Reset Problem (3019)

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

Event Date 01/02/2022

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 customer has reported that the vent shutdown and rebooted without warning.No patient health consequences have been reported.

Manufacturer Narrative

The investigation was based on the reported event and log file analysis of the affected evita v800 with serial no.Asnn-0016.Several times, attempts were made to acquire parts for an on-site examination at the manufacturer.Unfortunately, the requested printed circuit board assembly (pba m48.3) including the red and blue usd cards for hardware analysis have not been provided.The investigation of the provided log file confirmed that the affected device performed an unexpected, synchronized restart of the ventilation unit and the ecd on the reported time as a result of an access problem in the software task processing.The restart was alerted high priority audibly by activation of the secondary acoustic alarm (piezo speaker of the ventilation unit).As a safety feature of the system, the safety software analyzes and verifies proper function of the device.In case of a detected deviation regarding operation of the ventilation unit, the safety software triggers a synchronized restart of the ventilation unit and the display unit (ecd) 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 ambient allowing the patient for spontaneous breathing.The deviation will be indicated by activated auxiliary auditory alarm (piezo speaker of the ventilation unit).Single restart sequence of the ventilation unit takes up to 8 seconds until evita v800 automatically resumes the ventilation with the latest settings.The restart sequence of the ecd may take up to a maximum of 1 minute.In the meantime, the user can observe the already resumed ventilation and safety-relevant parameters such as fio2 concentration, minute volume and airway pressure in the oled-display of the ventilation unit.Finally, the alarm message "ventilation unit restarted" will be prompted on the screen with accompanying auditory alarm and the auxiliary auditory alarm ceases automatically.The complaint investigation confirmed an unexpected, synchronized restart of the ventilation unit and the ecd due to an access problem in the software task processing.The ventilator has alerted as specified and resumed ventilation after restarting in the last settings.The exact cause of the identified access problem could not be conclusively determined.The number of similar cases due to the same cause is within the expected range of the respective risk assessment and is therefore accepted.

Event Description

It was reported that: the customer has reported that the vent shutdown and rebooted without warning.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: 13277842
• MDR Text Key: 286164833
• Report Number: 9611500-2022-00014
• Device Sequence Number: 1
• Product Code: QOV
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: 01/07/2022
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2020
• 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