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

Catalog Number 8419601

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

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 unit shut down when they attempted to unplug the unit to transport the patient.They had been transported two other times.Plugged the unit in and then bagged the patient, completed transport and put on a different ventilator.There was no injury to the patient.

Manufacturer Narrative

The affected device was analyzed onsite by dräger service.The log book was not available.During the initial analysis the power supply was replaced.After replacement the device passed the test according to specification.A detailed evaluation of the power supply at the manufacturer found it to be fully functional and detected no deviation from specification.Based on the available information there is no indication of a device malfunction.It is likely that the batteries were depleted and did not have sufficient charging time between the transports.The device displays the current battery status and generates an alarm informing the user about the remaining battery capacity when it goes below specified levels.In case the device is not plugged in and the battery depletes, the user would be alerted to this condition by an audible power failure alarm according to iec 60601-1-8 for at least 2 minutes and the emergency-breathing valve would open allowing spontaneous breathing.

Event Description

Please refer to the initial-report.

• 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
• MDR Report Key: 8076898
• MDR Text Key: 128400116
• Report Number: 9611500-2018-00362
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K083050
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: 8419601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1