MAUDE Adverse Event Report: ST PAUL PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING CIRCUIT CIRCULATOR

Catalog Number C1038J

Device Problem Gas/Air Leak (2946)

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

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Information received a smiths medical breathing|portex general anesthesia circuits malfunctioned.During a pre-use check, the customer found leakage of air from the breathing bag.No patient injury.

Manufacturer Narrative

Other text: d4: udi information is unknown.G5: premarket (510k) number is unknown.Additional information in h3, h6 and h10.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The sample observed shows no damage and the leak test inspection was accepted.Based on the inspection, it can't be confirmed failure mode reported for leakage in the breathing circuit assembly.Root cause cannot be determined based on investigation.No corrective actions were taken since the investigation did not reveal the failure reported.No problems or issues were identified during this device history record review.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 11845261
• MDR Text Key: 251347227
• Report Number: 3012307300-2021-04561
• Device Sequence Number: 1
• Product Code: CAG
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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 Expiration Date: 07/22/2023
• Device Catalogue Number: C1038J
• Device Lot Number: 4026556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 08/01/2021
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: Asian