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	06/03/2022
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.They have a child that is being treated with the 3100a for 2.5 days, and the circuit/hose has a cable tie in place to make it leak tight.The circuit is warm, and the plastic feels much softer that it did when it was set up, which maybe the reason it is not gripping the connector properly.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.
Additional Manufacturer Narrative
H3: 81: other- the suspect device is not available for return, as it was discarded after the treatment.Sample photo was evaluated and confirmed the reported issue.It was determined that manufacturing personnel may be related with the reported defect since the spm 11518-16vs etal states that the correct method to package the fg is by making a clockwise circle with the heated wire and then a another circle against clockwise with the circuit body, and lastly introducing the other components inside the bag.If personnel do not follow these instructions correctly, the type of defect reported in this complaint may occur.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: 14978596
• Report Number: 8030673-2022-00259
• Device Sequence Number: 14707927
• 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?: No
• 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): 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 Age: 14 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG