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

Model Number PACKAGE ASSEMBLY,INFANT FLOW,LP

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3: 81 other - the sample has not been returned for evaluation.Therefore, no root cause determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : the sample was not yet returned.

Event Description

It was reported to vyaire medical that the exhaust tubing disconnected from the generator head while on a baby.There was a condensation around the tube and mask when the disconnect occurred.

• Brand Name: INFANT FLOW LP NCPAP GENERATOR SET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18965987
• MDR Text Key: 338430889
• Report Number: 2021710-2024-18916
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Device Catalogue Number: 7772020LP
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2024
• 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: Initial
• Patient Sequence Number: 1