MAUDE Adverse Event Report: PORTEX; BREATHING-CIRCUIT

Model Number C37101307J

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that immediately after starting to use the smiths medical product, the customer noticed air was leaking from the anesthesia circuit.No patient injury.

Manufacturer Narrative

Other, other text: device evaluation- one device was returned for evaluation.Visual inspection was performed; no discrepancies were identified.The device was given functional testing; this showed the device passed with no leakage.The reported issue was not confirmed.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• MDR Report Key: 10912741
• MDR Text Key: 218517652
• Report Number: 3012307300-2020-11852
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C37101307J
• Device Catalogue Number: C37101307J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1