MAUDE Adverse Event Report: VYAIRE MEDICAL. LONG PAT CKT,F&P850, BOX 4, 31A; VENTILATOR, HIGH FREQUENCY

Model Number LONG PAT CKT,F&P850, BOX 4, 31A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported a defective 3100a circuit, the customer explained that when they connect the circuit on the unit, the heater alarmed, they tried a new temp ports and humidifier but the device still alarming.The customer replaced the circuit and solved the issue.The problem happened while connected on a patient, however, the customer also confirmed that there was no harm or injury that was associated with the event.

Manufacturer Narrative

Device evaluation: g4, h2, h3, h6 and h10.Result of investigation: the vyaire failure analysis laboratory performed functional test on the sample received and no deviations to manufacturer specification were found.Therefore the defect reported by the customer was not confirmed and root cause cannot be determined.

• Brand Name: LONG PAT CKT,F&P850, BOX 4, 31A
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9673498
• MDR Text Key: 188823754
• Report Number: 8030673-2020-00072
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446003373
• UDI-Public: (01)20846446003373
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LONG PAT CKT,F&P850, BOX 4, 31A
• Device Catalogue Number: 773997
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention