MAUDE Adverse Event Report: VYAIRE MEDICAL INC. BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L; VENTILATOR, HIGH FREQUENCY

Model Number	BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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
The customer reported that the boxed patient circuit assy, 3100a, 850s broke apart.It happened during setup, prior to patient use.
Additional Manufacturer Narrative
"device evaluation: result of investigation: no physical sample was sent for investigation, however a picture of the fg was provided where we can dee a disconnection on one of the circuit joints.The lot number was not provided and we were unable to review the device history record.We need the physical sample to perform a further investigation, therefore the root cause was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.".

• Brand Name: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• 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 via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15526087
• Report Number: 8030673-2022-00271
• Device Sequence Number: 2584104
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Device Catalogue Number: 29028-011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 02/06/2023
• 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
• Patient Sex: Unknown