MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the vital signs® adult anesthesia breathing circuit are being built with a different hme (heat and moisture exchanger) size.The hme located between the elbow and wye of the affected circuits are visibly much smaller than they should be.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: according to the investigation, pictures and samples provided were inspected visually finding that the circuits were assembled with the wrong filter.As a resolution, personnel were retrained on the correct assembly method.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11317999
• Report Number: 8030673-2021-00148
• Device Sequence Number: 19654070
• Product Code: CAI
• UDI-Device Identifier: 10190752120792
• UDI-Public: (01)10190752120792(11)20200817(10)0004155375
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: A5U580A4
• Device Lot Number: 0004155375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1