MAUDE Adverse Event Report: VYAIRE MEDICAL ENVE VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Moisture or Humidity Problem (2986)

Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 07/05/2019

Event Type  malfunction  

Event Description

The physician was called with patient tachypnea and oxygen desaturation, respiratory rate 40.The ventilator was set for a rate of 12 and the patient was not breathing on own, but the vent was showing that the patient was over breathing on the graph.Sedation was increased - propofol, versed, dilaudid - with no relief.Patient sedated to 83%.Continued propofol, versed, dilaudid and nimbex x1 dose given.A vent issue was noted so the ventilator was replaced by respiratory therapy.After all of the above, the respiratory rate returned to normal.It was confirmed it was a vent issue and not a sedation/patient issue.Follow up: respiratory therapy staff examined the enve ventilator and determined that excessive moisture in the pressure line was causing the autocycling.The patient circuit was replaced, and the ventilator ran for 8 hours with no problems.Vent next brought to biomedical engineering and checked history and nothing relevant was noted.Ran unit.Determined with respiratory therapy manager that unit was ok to return to service.

• Brand Name: ENVE VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 8793037
• MDR Text Key: 151121922
• Report Number: 8793037
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA