MAUDE Adverse Event Report: PORTEX; BREATHING CIRCUIT CIRCULATOR

Lot Number 4053437

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Customer facility phone number: (b)(6).

Event Description

Information was received indicating that a smiths medical breathing circuit had a pinhole in it.There was no patient injury and no reported adverse events.

• Brand Name: PORTEX
• Type of Device: BREATHING CIRCUIT CIRCULATOR
• MDR Report Key: 12018473
• MDR Text Key: 256775314
• Report Number: 3012307300-2021-06181
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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: Health Professional
• Device Expiration Date: 09/29/2023
• Device Lot Number: 4053437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 08/01/2021
• Supplement Dates FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1