MAUDE Adverse Event Report: VYAIRE MEDICAL INC INFANT FLOW¿; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	7772020LP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the skin integrity of the nasal septum was damaged following use of device.Patient harm was reported: skin integrity of nasal septum broken, erythema pain, infection requiring antibiotic therapy.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - 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: INFANT FLOW¿
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 19763347
• Report Number: 3013421741-2024-00279
• Device Sequence Number: 15604396
• Product Code: BZD
• UDI-Device Identifier: 10190752156531
• UDI-Public: (01)10190752156531
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7772020LP
• Device Catalogue Number: 7772020LP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown