MAUDE Adverse Event Report: NULL PORTEX; BREATHING-CIRCUIT

Model Number CA13K0/400/000JP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.(b)(4) owns all complaint handling, complaint investigations and reporting responsibilities.We issued complaint notification to the supplier "(b)(4)", requesting them to investigate the event.

Event Description

It was reported that during the pre-use check, the hme filter got detached with just a little force.No patient injury.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 13170018
• MDR Text Key: 283260738
• Report Number: 3012307300-2022-00130
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

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 Model Number: CA13K0/400/000JP
• Device Catalogue Number: CA13K0/400/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1