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

Catalog Number 8414900

Device Problems Device Emits Odor (1425); Inappropriate or Unexpected Reset (2959); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported in the adverse incident report by the user: "patient ventilated.Loud bang from the cubicle, ventilator high pitch ring, turned itself off, and then switched itself back on.Strong smell of burning from the ventilator.No smoke observed.Back of ventilator felt hot on the back.The patient was taken off the ventilator immediately and put onto another one." no patient consequences reported.

Manufacturer Narrative

The investigation was based on the reported information and the information about the service performed by the customer.The log file and replaced power supply of the affected device were requested, but have not been received for the investigation.The customer reported that the power supply was replaced and a subsequent device check passed without deviation.Based on the part number the power supply was manufactured before 2005.As no further information was provided, a detailed analysis could not be performed.The evita power supply is designed and approved in accordance to the requirements of underwriters laboratories inc.Thus, the risk of fire is minimized in case of an overloaded component.In case of a detected deviation in the power supply the device initiates warmstart in an attempt to solve the issue.During a warmstart the screen is switched to dark and an emergency-breathing valve opens to allow for spontaneous breathing.This is accompanied by an audible alarm.In the event of an unsuccessful warmstart due to a permanent hardware problem, a continuous audible alarm is kept activated and the emergency-breathing valve remains open allowing spontaneous breathing.Manual ventilation with an alternate device may be considered necessary.It was concluded that the device reacted as specified and was repaired by replacement of the power supply.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

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: 8073083
• MDR Text Key: 127356733
• Report Number: 9611500-2018-00358
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• 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: 8414900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1