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

Device Problems Device Emits Odor (1425); Loss of Power (1475); Smoking (1585); Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/02/2019

Event Type  malfunction  

Event Description

The intubated and vented patient needed to be turned.When the nurse began to turn the patient, the ventilator started alarming, low peep, low tv, three more red alarms, a puff of smoke appeared from right posterior aspect of vent.Along with an electrical smell and then a huge triangle appeared on the ventilator face and it stopped working.Patient's sats dropped to 70's.The nurse was connecting ambu bag to oxygen, charge nurse came in room.We began bagging patient and sats returned to 90s and the ventilator was exchanged.Dr.Had walked into room while bagging patient and ventilator exchange was occurring.Respiratory therapy marked the ventilator defective and the ventilator was brought to biomedical engineering for an examination.Biomed verified the issue and will be sent to vyaire for inspection.

• Brand Name: ENVE
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 8611521
• MDR Text Key: 145105958
• Report Number: 8611521
• 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: 03/25/2019,03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA