MAUDE Adverse Event Report: NULL; ANESTHESIOLOGY

Device Problem Gas/Air Leak (2946)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that during pre-test, leakage of air from the product was observed.No patient injury reported.No additional information is available for this complaint.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection results: observation of the returned breathing circuit revealed no abnormalities such as damage related to the reported event.Functional testing: we conducted a leak test on the breathing circuit, but no leaks were confirmed, and it was confirmed that the product conformed to the standard.The reported event was not confirmed.The cause of the reported problem could not be determined.

• Type of Device: ANESTHESIOLOGY
• Manufacturer (Section G): NULL
• MDR Report Key: 13736654
• MDR Text Key: 287031439
• Report Number: 3012307300-2022-04471
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1