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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the 7772020lp package assembly, infant flow, lp came apart while connected to a patient.They had to change the whole set as a result.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
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.
Additional Manufacturer Narrative
Result of the investigation: the customer sent photos but did not submit the lot number/physical sample for investigation.A physical sample is required as evidence to conduct a better investigation and determine the cause of the problem.As part of the investigation the device history record should be reviewed.However, we were unable to review the device history record since the lot number was not provided for the investigation.Therefore, the defect reported by the customer was not confirmed.

• 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 ; 2402760001
• MDR Report Key: 17506914
• Report Number: 8030673-2023-00346
• Device Sequence Number: 20457035
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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