MAUDE Adverse Event Report: VYAIRE MEDICAL; BREATHING CIRCUIT

Catalog Number AFN52004

Device Problem Melted (1385)

Patient Problem Hypoxia (1918)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire that a patient could not be ventilated during intubation.The patient was quickly removed from the circuit and provided positive pressure ventilation via manual resuscitator.During this time, the physician noticed that the circuit was defected.The customer reported that the circuit had a 4 ½ section that was melted/chaffed with holes.

Manufacturer Narrative

The device sample was received by our quality team.A visual inspection was performed and a melted area was noted on the tube, therefore the failure reported was confirmed.Based on the investigation, the root cause was determined that "equipment an personnel" are considered to contribute to the failure.

• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7866299
• MDR Text Key: 119924451
• Report Number: 8030673-2018-00013
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFN52004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention