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

Model Number	BOXED PAT CIRCUIT ASSY, 3100A, FLTRD, 850L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.Therefore, no root cause could be determined.The customer sent a picture however, we are unable to confirm if the tube or component were loose on their connection to have caused a leak between them, we need the physical sample for further investigation.The device history record was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released on 10june2021 per our internal procedures and no issues were found.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 during ventilator use, the end user noticed a leak and traced it to the boxed pat circuit assy,3100a,fltrd,850l.It was on the inspired side after the humidifier.It was loose on the connector, allowing gas to escape.End user fixed the leak with a cable tie, and treatment was not interrupted.No harm is associated with the event.

• Brand Name: BOXED PAT CIRCUIT ASSY, 3100A, FLTRD, 850L
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la producciion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14741276
• Report Number: 8030673-2022-00255
• Device Sequence Number: 14851941
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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
• Device Lot Number: 0004188661
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/19/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown