MAUDE Adverse Event Report: VYAIRE MEDICAL PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS; Ventilator, non-continuous (respirator)

Model Number	PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
Plastic interface connecting to generator broke in half while used on baby not during manipulation of interface.Noted as baby was crying in isolette.The generator was changed, new generator integrity was examined and determined to be safe.

• Brand Name: PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS
• Common Device Name: Ventilator, non-continuous (respirator)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwood blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erin salbilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17625153
• Report Number: 8030673-2023-00349
• Device Sequence Number: 12583619
• Product Code: BZD
• UDI-Device Identifier: 10190752152687
• UDI-Public: (01)10190752152687
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/25/2023

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,GENERATOR WITHOUT PRONGS
• Device Catalogue Number: 7772000LP
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/25/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown