MAUDE Adverse Event Report: VYAIRE MEDICAL INC. INFANT FLOW¿; Ventilator, non-continuous (respirator)

Model Number	777002M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
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 vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that a 26-day premature newborn (27 sa) receiving non-invasive ventilation with continuous positive nasal pressure on inflant flow (variable-flow nasal generator), alternating m and l mask sizes to vary pressure points.After 3 hours wearing a size m mask, the baby showed a very marked depression at the bottom of the columella.The skin remains sunken despite massage, and is slightly blackened.The device was not kept for analysis.No serious injury reported, however there is a risk of bedsores.

• Brand Name: INFANT FLOW¿
• Common Device Name: Ventilator, non-continuous (respirator)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; 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: 19651736
• Report Number: 8030673-2024-00381
• Device Sequence Number: 6578991
• Product Code: BZD
• UDI-Device Identifier: 10190752151956
• UDI-Public: (01)10190752151956
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 777002M
• Device Catalogue Number: 777002M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/01/2024
• 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