MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP NCPAP GENERATOR SET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	PACKAGE ASSEMBLY,INFANT FLOW,LP
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Erosion (2075)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the use of the 7772020lp - package assembly,infant flow,lp nasal prongs for cpap (continuous positive airway pressure) resulted in pressure wounds/red marks on the patient's nose.Issue was quickly identified, and the prongs were replaced by a face mask, and the reddened areas at nares eventually improved.It was stated that the nasal prongs are not as soft as the ones from their previous supplier.
Additional Manufacturer Narrative
The customer did not send physical sample, pictures, or provide a lot number since the sample was disposed.Therefore, no root cause could be determined.The issue was occurred with two patients.Please see (b)(4) for the second patient.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Sample was disposed.

• Brand Name: INFANT FLOW LP NCPAP GENERATOR SET
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16112737
• Report Number: 8030673-2023-00288
• Device Sequence Number: 15200282
• Product Code: BZD
• UDI-Device Identifier: 10190752156531
• UDI-Public: (01)10190752156531
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Device Catalogue Number: 7772020LP
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 01/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown