MAUDE Adverse Event Report: NULL; BREATHING CIRCUIT CIRCULATOR

Lot Number 210810

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Event Description

It was reported that during pre-test, leakage of air from the breathing bag was detected.Also, a pinhole was found in the bag.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other text: additional information added to h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.A leak test of the breathing bag confirmed that the pressure did not rise and it did not conform to the standard.The root cause of the reported issue was found to be due to pinholes on the breathing bags.Actions were taken to mitigate the reported issue: a supplier notification was initiated.

• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section G): NULL
• MDR Report Key: 12628583
• MDR Text Key: 276354335
• Report Number: 3012307300-2021-09949
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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 Lot Number: 210810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 04/28/2023
• 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