MAUDE Adverse Event Report: VYAIRE MEDICAL OY CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the circuit coax (a) 2.4m, b.Ext, 2l bag gse experienced leaks greater than 750 mls.The incident occurred during testing in between patients.The occurrence caused significant delays in the operating lists.There were no reports of injury/harm to the patient.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15263317
• MDR Text Key: 305349377
• Report Number: 3010838917-2022-00006
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752136908
• UDI-Public: (01)10190752136908(10)203132
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2022

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
• Device Operator: Health Professional
• Device Model Number: CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE
• Device Catalogue Number: M1152226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1