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 Integrity Problem (2978)
Health Effect - Clinical Code	Distress (2329)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the 7772020lp package assembly,infant flow,lp plastic assembly of generator broke apart into 2 pieces.It was in use on a premature baby and the baby's ventilation was interrupted and a new generator had to be connected to fabian ventilator and attached to headgear.Which resulted in unnecessary discomfort, breathing difficulty and stress.
Additional Manufacturer Narrative
Additional information:g3, g6, h2 and h10 the customer confirmed that the reported event is a single incident and has already been reported.This complaint is a duplicate of (b)(4).Please refer to the original medwatch report submitted under mfr report # 8030673-2023-00346.Please disregard and void vyaire reference number:(b)(4) under mfr report # 3010838917-2023-00079.

• 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 vã­a de la producciã³n; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17657780
• Report Number: 3010838917-2023-00079
• Device Sequence Number: 17909424
• Product Code: BZD
• UDI-Device Identifier: 10190752156531
• UDI-Public: (01)10190752156531
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/25/2023
• 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
• Patient Sex: Unknown