MAUDE Adverse Event Report: NULL PORTEX; BREATHING-CIRCUIT

Model Number 450964-NL

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Ninth occurrence of separation from the circuit to the blue filter as well as from the elbow to the y part of the circuit.Occurring when patients are asleep and supine in the prone position.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12980938
• MDR Text Key: 282096085
• Report Number: 3012307300-2021-12646
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450964-NL
• Device Catalogue Number: 450964-NL
• Device Lot Number: 4150589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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