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	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the plastic in which the boxed pat circuit assy,3100a,fltrd,850l is made from is not sufficiently rigid for its purpose.Their 3100a had a patient which was cutting out suddenly and not restarting.Upon checking, the tube between the ventilator and the humidifier was bent over, not allowing gas to get into the circuit.End user then repositioned the hose and taped it to the side of the 3100a for support.No harm is associated with the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Result of investigation: the suspect device is not available for return, as it was discarded after the treatment.Sample photo without lot number was sent for the investigation and in the picture it can be seen that the tube part was slightly bent.Therefore the defect reported by the customer was confirmed.

• 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: 14978478
• Report Number: 8030673-2022-00258
• Device Sequence Number: 14875471
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820(10)0004188661
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Device Catalogue Number: 29028-011
• Device Lot Number: 0004188661
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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