MAUDE Adverse Event Report: WESTMED, INC. ANESTHESIA BREATHING CIRCUIT KIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number 9313

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2016

Event Type  malfunction  

Event Description

During surgery, anesthesiologist suspected patient was not responding to anesthetic agent, sevoflurane.Case was just getting started.At first it was thought that the problem was with the anesthesia ventilator, but md requested switching out the patient's breathing circuit.Problem was resolved.

• Brand Name: ANESTHESIA BREATHING CIRCUIT KIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): WESTMED, INC.; 5580 s. nogales hwy.; tucson AZ 85706
• MDR Report Key: 6135884
• MDR Text Key: 61151712
• Report Number: 6135884
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.