MAUDE Adverse Event Report: NULL; ANESTHESIA BREATHING CIRCUIT

Model Number CA24K0/4K2/004JP

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

It was reported that during pre-test, a part of the product was found damaged.No patient injury reported.No additional information available for this complaint.

Manufacturer Narrative

Other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Dhr review was not done as the lot number was not available.

• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12577987
• MDR Text Key: 274790575
• Report Number: 3012307300-2021-09762
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA24K0/4K2/004JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1