MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4; VENTILATORS, INTENSIVE CARE

Catalog Number 8411740

Device Problems No Audible Alarm (1019); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

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 a patient was ventilated with 100% o2.After a blood gas analysis, the device was switched to 70% o2.While continuing the procedure, it was noticed that the patient became instable.During root cause analysis, it was found that the evita was switched to standby without any audible alarm.No patient consequences were reported.

Manufacturer Narrative

The device was available for the manufacturer investigation.However, the pcb cpu had already been replaced by the company achtzehn, who performs the service and maintenance in the hospital, and was not made available, so that the logbook stored on the board could not be evaluated.In the course of the device investigation it was determined that the sealing on the touch screen frame of the evita 4 was not installed.Furthermore, the touch screen frame was broken at several points.This allowed liquid to enter the touch screen control panel, damaging the circuit paths located behind it.In the test at manufacturer site, the standby button was resistively measured while water and hand disinfectant was added.The device did not show the reported behaviour, but behaved as specified and only switched itself off with the help of the user.However, in the unlikely event that the ingress of liquid significantly reduces the resistance of the standby button, it is basically possible for the device to automatically switch to standby mode without any user intervention.In such a case, the evita 4 alarms visually and acoustically with the warning "standby activated !!!" this alarm remains active until the user confirms the alarm by pressing the hardkey "alarm reset".If the "alarm reset" key also has an erroneous low impedance, a continuous acoustic alarm is triggered.The cpu circuit board replaced as a precaution by the company achtzehn cannot cause an unwanted switchover to standby.In standby mode, the patient can breathe spontaneously via the emergency breathing equipment.Based on the available information and the device, it could not be clarified with certainty whether the mode switchover was accidentally performed by a user or due to a technical defect.After the mode change there is always an acoustic alarm.It has been reported that this alarm was not given.As the investigation showed that the "alarm reset" key and the acoustic alarm unit were functional, we cannot confirm this.However, it could be established with certainty that the control panel of the device was in an unsuitable condition for safe operation.This should have been detected during maintenance.

Event Description

Please refer to the inital report.

• Brand Name: EVITA 4
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8564058
• MDR Text Key: 143689507
• Report Number: 9611500-2019-00135
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K980642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8411740
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1