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

Catalog Number CA17K0/000/004JP

Device Problem Defective Device (2588)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Udi section, information is unknown.No information to date.Device is exempt.Device evaluation: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.Observation of the returned breathing circuit and breathing bag revealed no abnormalities such as damage related to the reported event.Next, we conducted a leak test on the breathing circuit and breathing bag, but no leaks were confirmed.The reported event was not confirmed.The root cause was unable to be identified.The dhr review was done, no issues related to the original complaint were found.We will notify manufacturing site of the occurrence of this event and record this event in a database to monitor the future occurrence status.

Event Description

It was reported that an error occurred in the product during the pre-use check.No patient involvement.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 16584240
• MDR Text Key: 311744395
• Report Number: 3012307300-2023-02788
• 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
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA17K0/000/004JP
• Device Lot Number: 221124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2023
• 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