MAUDE Adverse Event Report: VYAIRE MEDICAL OY PATIENT CIRCUIT, ADULT 60" CORR HOSE; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE

Model Number PATIENT CIRCUIT, ADULT 60" CORR HOSE

Device Problem Leak/Splash (1354)

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

Event Date 08/22/2022

Event Type  Injury  

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.

Event Description

It was reported to vyaire medical that the patient circuit, adult 60" corr hose had a leakage.On the first case in the morning, they were about to move a patient from a supine position to a prone position.During the time when the head piece was being put on the patient,they could not manually or mechanically ventilate the patient.They ventilated the patient with an ambu bag and replaced the patient circuit.This resolved the issue and they were able to vent the patient.The issue occurred 3 different times over the weekend and it failed the leak test.No patient consequence was reported.

• Brand Name: PATIENT CIRCUIT, ADULT 60" CORR HOSE
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki etel; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): GLOBALMED INC.; 155 north murray st.,trenton; ontario, K8V 5 R5; CA K8V 5R5
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15433279
• MDR Text Key: 300029029
• Report Number: 3010838917-2022-00013
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PATIENT CIRCUIT, ADULT 60" CORR HOSE
• Device Catalogue Number: M1012142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• 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