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

Device Problems Protective Measures Problem (3015); Ventilation Problem in Device Environment (3027)

Patient Problem Injury (2348)

Event Date 10/21/2018

Event Type  Injury  

Manufacturer Narrative

The investigation was started but is not yet concluded.A follow-up report will be send as soon the investigation is closed.

Event Description

Patient was ventilated in bipap-mode with the ventilator.The oxygen concentration was increased from 21 % to 40 %.The device went on itself to stand-by mode.Ventilation consequently did not go on.Generally it needs two steps to turn the device into stand-by mode, for which reason an accidental turn-off is excluded to be a possible reason.Patient injury was reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

During the logfile analysis no malfunction of the device was found.The event occured on (b)(6) 2018 at about 3 pm.Summarized the following log-entries were saved on the date of event: in standby-mode which was set since several days, the o2- and flow-calibration was done successfully.From 2:50 pm the value of the o2-concentration was increased several times.At 3:15 pm a ventilation-mode was pre-set as well as standby-mode was stopped, this means ventilation was started.There is no indication that the evita 4 went into standby-mode on its own.To turn the device into standby-mode the user has to confirm the selection and an alarm is generated.The display shows clearly that the device is in standby-mode.A description how to change the ventilation mode and warnings are described in the instructions for use in detail.In standby-mode the safety-valve is open, accordingly spontaneous breathing is possible.Before returning the device to user it should get checked according to service documentation.The device behaved according to its specification.

• 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: 8027372
• MDR Text Key: 125746826
• Report Number: 9611500-2018-00346
• 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: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1