MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AFN119X4

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, vyaire medical has not received the suspect device/component for evaluation.If the customer provides the sample for further investigation or additional information is obtained, vyiare will provided a supplemental report.

Event Description

The customer reported that there was a leak in the anesthesia circuit during patient use and mechanical ventilation was not possible.The circuit was replaced and the issue was resolved.No patient harm was reported.

Manufacturer Narrative

As of this time, vyaire medical has not received the suspect device for evaluation.If the device is returned then a supplemental report will be submitted after an investigation is completed.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7448413
• MDR Text Key: 106249872
• Report Number: 8030673-2018-00420
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFN119X4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other