MAUDE Adverse Event Report: NULL

Lot Number 210708

Device Problem Crack (1135)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the breathing circuit was returned.As a result of observing the sample, melting and dents were confirmed.When a leak test of the breathing circuit was performed, the pressure did not rise and a leak was confirmed.The reported event was confirmed.The root cause may be due to manufacturing.The sample was sent for further investigation.Dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.

Event Description

It was reported that during the pre-use check, a crack in the breathing circuit was found and leakage of air was observed.No patient injury was reported.

• Manufacturer (Section G): NULL
• MDR Report Key: 13197401
• MDR Text Key: 285681024
• Report Number: 3012307300-2022-00333
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 210708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• 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