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

Catalog Number 8413940

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem Death (1802)

Event Date 05/15/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient disconnected from the ventilator during ventilation which was not alarmed appropriately by the device.On (b)(6) the patient was declared brain dead and on (b)(6) the patient expired.

Manufacturer Narrative

The log file of the affected device was provided for the investigation.During further communication with the customer it was stated that they do not believe that the device malfunctioned.There is no log entry regarding a technical malfunction during the event.On the date of event prior to the reported time of event ventilation-related alarms were silenced by the user by pressing the button ¿alarm pause¿ on multiple occasions which indicates that the audible alarms worked as specified.Based on the log file the ventilator detected and alarmed ¿mv low¿, ¿airway pressure low¿ and ¿apnea¿ before and during the reported event.Both ¿minute volume (mv) low¿ and ¿airway pressure low¿ indicate a leakage or disconnection in the breathing circuit.¿apnea¿ is alarmed in case no expiratory flow is measured after the user set apnea-time is exhausted.As a result, the device switches to the volume-controlled apnea ventilation.It can be concluded that the device reacted as specified to a leak in the breathing system by posting the corresponding alarms.As some of these alarms were silenced by the user, there is no indication of a device malfunction.

Event Description

It was reported that the patient disconnected from the ventilator during ventilation which was not alarmed appropriately by the device.On 5/15 the patient was declared brain dead and on 5/22 the patient expired.

• Brand Name: EVITA XL
• 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: 10122123
• MDR Text Key: 194098819
• Report Number: 9611500-2020-00190
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083050
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8413940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/14/2020
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2006
• 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): Death