MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CAI

Catalog Number CA24K0/4K2/004JP

Device Problem Break (1069)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, a pinhole in the breathing bag was found.When the customer attempted to detach the breathing bag from the connector, the bag got torn.No patient injury was reported.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be confirmed.However, it is concluded that failure reported could not be reproduced therefor the damage was after the product left shm facilities.Dhr review was not completed as no lot number was provided.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CAI
• Manufacturer (Section G): NULL
• MDR Report Key: 13169783
• MDR Text Key: 286859729
• Report Number: 3012307300-2022-00122
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA24K0/4K2/004JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1