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

Catalog Number 8422500

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2022

Event Type  Injury  

Event Description

It was reported that: an insufficient o2-flow was delivered.The patient had to be resuscitated.No other injuries were reported as a result of the situation.

Manufacturer Narrative

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

Event Description

It was reported that: an insufficient o2-flow was delivered.The patient had to be resuscitated.No other injuries were reported as a result of the situation.

Manufacturer Narrative

The device was examined by dräger service and the log file was provided for further analysis.The examination of the device by dräger service and the log file analysis could not confirm any malfunction of the device at the indicated time.The reported device behaviour could not be reproduced.The ventilator was ventilating the patient at the settings established by the user.Based on the log file entries, no alarm situation was present at the reported time.A system test and breathing tube system test were performed by the user on the reported day prior to therapy, which did not reveal any deviations.The safety software of the device continuously analyses the correct device function.In case ventilation relevant parameters exceed or fall below the defined alarm limits, the device issues a visual and acoustic alarm message via the display to inform the user of an existing problem.Based on the investigation results this case is no longer considered to be reportable.

• 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: 15594815
• MDR Text Key: 301637275
• Report Number: 9611500-2022-00279
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• 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
• Patient Outcome(s): Life Threatening