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

Model Number PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 321977681
• Report Number: 8030673-2023-00349
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10190752152687
• UDI-Public: (01)10190752152687
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/25/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention