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

Catalog Number 8414900

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The affected device was analyzed by the hospital¿s technical department.The log file was not available for analysis.It was reported that the power supply was determined to be the root cause.The replacement corrected the issue and the faulty power supply was disposed of.In case of a power supply failure and ongoing ventilation would stop and 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.During power failure an emergency-breathing valve would open allowing for spontaneous breathing.Manual ventilation with an alternate device may be considered necessary.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

It was reported the device shut down during patient ventilation in the icu.The user stated that the vent made a squealing sound and then shut off.No patient injury was reported.The patient had to be bagged while a replacement vent was brought down.

• 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11528011
• MDR Text Key: 249976446
• Report Number: 9611500-2021-00119
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K051263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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?: No
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1