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

Model Number INFANT FLOW LP NASAL MASK MEDIUM

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 327419225
• Report Number: 2021710-2023-18362
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10190752151956
• UDI-Public: (01)10190752151956(10)0004238761
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention