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	Disconnection (1171)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer reported the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Several attempts were made to contact the distributor to obtain necessary information regarding the event.At this time, no response was received and lot information is unknown.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the breathing circuit seems to come apart at the elbow very easily.At this time, patient involvement is unknown.
Additional Manufacturer Narrative
H3: code 81 other- at this time, vyaire has not received the suspect device for evaluation.Sample is necessary to confirm disconnection of circuit reported by the customer.Therefore the defect reported by the customer was not confirmed and root cause cannot be determined.Any additional information received from the customer will be included in a follow-up report.

• 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: 9661670
• Report Number: 8030673-2020-00070
• Device Sequence Number: 3392770
• Product Code: CAI
• UDI-Device Identifier: 10190752121546
• UDI-Public: (01)10190752121546
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2020

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: ADU52914
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1