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

Device Problem Connection Problem (2900)

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

Event Date 09/01/2022

Event Type  malfunction  

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 Description

The customer reported that the boxed patient circuit assy, 3100a, 850s broke apart.It happened during setup, prior to patient use.

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
• Type of Device: 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
• MDR Text Key: 304892212
• Report Number: 8030673-2022-00271
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 10/01/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/06/2023
• 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