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

Model Number	INFANT FLOW LP NASAL MASK MEDIUM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 asked the customer to hold onto items/packaging that are in question.This report is for the infant flow lp nasal mask medium.Please see (b)(4) for infant flow lp nasal mask small, (b)(4) for infant flow lp nasal prongs medium and (b)(4) for infant flow lp nasal prongs small.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical problem with infant flow lp nasal mask in which the mask and prong kinked, preventing the baby from breathing.Attempts were made by tightening or loosening sides, bigger and smaller masks, but did not help.Furthermore, there was not patient harm reported.The patient was taken off cpap (continuous positive airway pressure) and put on the heated mustache.

• Brand Name: INFANT FLOW LP NASAL MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18074468
• Report Number: 2021710-2023-18362
• Device Sequence Number: 15346681
• Product Code: BZD
• UDI-Device Identifier: 10190752151956
• UDI-Public: (01)10190752151956(10)0004238761
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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: INFANT FLOW LP NASAL MASK MEDIUM
• Device Catalogue Number: 777002M
• Device Lot Number: 0004238761
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown