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
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9673498
• Report Number: 8030673-2020-00072
• Device Sequence Number: 401210
• Product Code: LSZ
• UDI-Device Identifier: 20846446003373
• UDI-Public: (01)20846446003373
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LONG PAT CKT,F&P850, BOX 4, 31A
• Device Catalogue Number: 773997
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention