MAUDE Adverse Event Report: WESTMED, INC. 72 ADULT UNI-LIM COAXIAL ANESTHESIA CIRCUIT; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 9128

Device Problems Failure to Deliver (2338); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

The patient was induced and intubated without incident with a westmed 72' adult uni-lim¿ coaxial anesthesia circuit.Anesthesia was unable to ventilate the patient.Upon inspection, after the conclusion of the case, the inspiratory (inner) limb of the circuit was noted to be torturous with a limited diameter.

• Brand Name: 72 ADULT UNI-LIM COAXIAL ANESTHESIA CIRCUIT
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 11854843
• MDR Text Key: 251711179
• Report Number: 11854843
• Device Sequence Number: 1
• Product Code: CAH
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9128
• Device Catalogue Number: 9128
• Device Lot Number: 121420T52
• 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: 05/12/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16790 DA