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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

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 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.

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
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, ca
• MDR Report Key: 10498338
• MDR Text Key: 206394566
• Report Number: 8030673-2020-00119
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 70846446005907
• UDI-Public: (01)70846446005907(10)0004115206
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1