MAUDE Adverse Event Report: PORTEX; BREATHING-CIRCUIT

Catalog Number CA1700/000/000JP

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, the customer noticed air was leaking from the breathing bag, which did not allow him to use the product.No patient involvement.

Manufacturer Narrative

H10 device evaluation results: one portex general anesthesia circuit was returned for investigation in used condition.The sample was visually inspected at a distance of 12 inches under normal lighting.A pinhole was found in the circuit.The customer reported product problem was therefore confirmed.The problem source of the reported product problem was unknown.A root cause was not established.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• MDR Report Key: 11105148
• MDR Text Key: 224741560
• Report Number: 3012307300-2021-00020
• Device Sequence Number: 1
• Product Code: CAI
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CA1700/000/000JP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1