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

Model Number	INFANT FLOW LP NASAL MASK MEDIUM
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 mask continually rolled under and collapsed on both patient's faces despite frequent repositioning which caused poor seal for cpap compromising respiratory status and caused upper lip irritation and redness.They switched to nasal prongs since the mask was not effective.The customer confirmed that there was no patient harm associated with the reported event.6 tests/lab data.

• Brand Name: INFANT FLOW LP NASAL MASK MEDIUM
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13214463
• Report Number: 8030673-2021-00228
• Device Sequence Number: 17472660
• Product Code: BZD
• UDI-Device Identifier: 10190752151956
• UDI-Public: (01)10190752151956(10)0004192610
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: 0004192610
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown