MAUDE Adverse Event Report: PORTEX; BREATHING-CIRCUIT

Model Number CP120J/200/000JP

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that during the use of the product, the anesthesia device issued a message of air leakage.Also, lowering in the ventilation was observed.Furthermore, a gap was found at the filter connection part.No patient injury.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• MDR Report Key: 12708226
• MDR Text Key: 278762465
• Report Number: 3012307300-2021-10368
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CP120J/200/000JP
• Device Catalogue Number: CP120J/200/000JP
• Device Lot Number: 210201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1