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

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 01/03/2020

Event Type  malfunction  

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 Description

The customer reported that the breathing circuit seems to come apart at the elbow very easily.At this time, patient involvement is unknown.

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
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9661670
• MDR Text Key: 196281210
• Report Number: 8030673-2020-00070
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752121546
• UDI-Public: (01)10190752121546
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: ADU52914
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1