MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101314J

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the customer conducted a pre-use check, with an anesthesia device connected to the product.And an air leak alarm went off.He suspected leakage of air occurred in the product because no alarm sounded when he checked the other one.No patient involvement.

Manufacturer Narrative

Device evaluation: one unit was returned for evaluation of the failure and pictures by the customer were provide it.Unit returned was received inside of a plastic bag which is not the original package.Samples were submitted to leak test inspection per specification qp 2025 rev.104 disposable anesthesia breathing circuit (dabc) / section 1.8 leak test.Leak test results: leak test inspection was performed on the returned device using equipment manometer id# 8.0562 (calibration due date 01/2023).Results: the devices don?t present leakage.Conclusions: based on the leak test results, the reported nonconformance is not confirmed.Root cause: root cause cannot be addressing since the failure mode reported is not confirmed.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 14135786
• MDR Text Key: 289447565
• Report Number: 3012307300-2022-06508
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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 Catalogue Number: C45101314J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/02/2022
• 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