MAUDE Adverse Event Report: NULL; BREATHING-CIRCUIT

Model Number C45101314J

Device Problem Device Alarm System (1012)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the product was detected.So the customer changed it to another new one.No patient injury.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Unit returned was received inside of a plastic bag which is not the original package.Sample was submitted to leak test inspection per specification qp 2025 rev.104 disposable anesthesia breathing circuit (dabc) / section 1.8 leak test results: leak test inspection was performed on the returned device using equipment manometer id# 8.0581 (calibration due date 01/2022).Results: the device doesn?t present leakage.Based on the leak test results, the reported nonconformance is not confirmed.No mitigation actions since the investigation did not reveal the failure reported action taken: no corrective actions were taken since the investigation did not reveal the failure reported the cause of the reported problem could not be determined.

• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12311182
• MDR Text Key: 266153203
• Report Number: 3012307300-2021-08338
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C45101314J
• Device Catalogue Number: C45101314J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1