MAUDE Adverse Event Report: VYAIRE MEDICAL INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer confirmed that there was no problem with the connection between the circuit and the generator and the cpap pressure was normal, but there is a leak from the safety valve.No root cause has been determined at this time, since the investigation is still ongoing.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 safety valve of 26405-001 infnt flw lp, ncpap, generator kit without prongs + circuit x20 was broken after 1-2 hours in clinical use.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: according to the investigation and the photo sent by the customer it could be seen that the p/n cf71-130c has a leak, so the defect was confirmed.However the part number cf71-130c is not manufactured at the mexicali facility, so the root cause is attributed to the non-conforming material.

• Brand Name: INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, ca
• MDR Report Key: 10498338
• Report Number: 8030673-2020-00119
• Device Sequence Number: 1218617
• Product Code: BZD
• UDI-Device Identifier: 70846446005907
• UDI-Public: (01)70846446005907(10)0004115206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
• Device Catalogue Number: 26405-001
• Device Lot Number: 0004115206
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/06/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1