MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ANESTHESIA CIRCUIT - LF; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	DYNJAA11094A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to the operating room (or) for a scheduled surgery.Anesthesiologist could not get the ventilator to deliver the prescribed tidal volumes.After multiple checks on the ventilator and circuit connections, the circuit tubing was changed.This intervention of changing the circuit allowed the prescribed volumes to be delivered to the patient.Meanwhile, the anesthesiologist was able to bag ventilate the patient to get desired tidal volumes.Manufacturer response for circuit, breathing (w connector, adaptor, y piece), medline industries, inc.(per site reporter): other defective anesthesia circuits were returned to the field representative.

• Brand Name: ANESTHESIA CIRCUIT - LF
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 20395473
• Report Number: 20395473
• Device Sequence Number: 6566203
• Product Code: CAI
• UDI-Device Identifier: 10195327683672
• UDI-Public: (01)10195327683672(10)24DBJ023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2024
• Report Date (Section F): 08/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: DYNJAA11094A
• Device Catalogue Number: DYNJAA11094A
• Device Lot Number: 24DBJ023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Date Report Sent to FDA: 08/01/2024