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

Catalog Number 8414900

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.Results will be provided in a follow-up report.

Event Description

It was reported that the device stopped due to empty batteries.This was unexpected for the user, although it's not clear if the batteries where fully loaded.No patient consequences reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The received information and the analysis performed on site provided basis for the manufacturer investigation.A check of the internal batteries by a service technician showed that the batteries had restricted capacity and less battery operating time.The batteries were thus replaced.Generally, the device switches to battery operation while generating a corresponding visible and audible alarm when the mains supply is not available.Prior to battery depletion the device generates the alarms ¿int.Battery only 2 minutes left !!¿ and ¿int.Battery discharged !!!¿.If the internal batteries are depleted the device shuts down with audible power failure alarm which lasts approximately two minutes.In this case the emergency-breathing valve is opened allowing spontaneous breathing of the patient.When mains supply is re-connected again the device starts with a warm start with the same settings as before and continues to ventilate the patient.As no device log file has been received in the course of investigation, it cannot be confirmed if the device alarmed as expected and if the batteries had sufficient time to charge prior to use.Batteries are wear parts and the remaining maximum capacity depends on aging over the life time, as well as on the extent and the way they are used, the charging cycle behavior defined by the user and potential variations in quality during manufacturing.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 10122142
• MDR Text Key: 194138309
• Report Number: 9611500-2020-00191
• 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: 06/07/2020

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 Catalogue Number: 8414900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1