MAUDE Adverse Event Report: VYAIRE MEDICAL. VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical performed a failure investigation and determined that personnel are related with the defect reported, since they assemble manually the tubing to connector.Personnel were retrained to assemble correctly as corrective action.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the vital signs¿ limb-o¿ single limb anesthesia breathing circuit is leaking while connected to patient during surgery however the customer confirmed that no patient harm was associated on this event.

• Brand Name: VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9771807
• Report Number: 8030673-2020-00081
• Device Sequence Number: 14241332
• Product Code: CAI
• UDI-Device Identifier: 10190752122338
• UDI-Public: (01)10190752122338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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 LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AFPXXXXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1