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	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: complete udi# was not provided by end user.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.
Event or Problem Description
It was reported to vyaire medical that the neonatal resuscitation team has been experiencing difficulties using the infantflow nasal mask size m colour blue (ref:777002m).The mask becomes deformed by the humidity in the incubator and flattens, causing leaks and breathing difficulties for babies, leading in some cases to malaise.The mask must be changed several times a day to avoid this problem.The problem is observed with all batches of size m, whereas it rarely occurs with masks of other sizes (777002xs, 777002s, 777002l, 777002xl).No patient harm was reported.Once mask was changed, patient became stable.

• 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 ; 2402760001
• MDR Report Key: 19978270
• Report Number: 3013421741-2024-00338
• Device Sequence Number: 8082949
• 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: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/13/2024
• 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