MAUDE Adverse Event Report: VYAIRE MEDICAL INSPIRATORY LINE HTD 8FT ADULT 20/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number	INSPIRATORY LINE HTD 8FT ADULT 20/CS
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 4681-504-inspiratory line htd 8ft adult 20/cs started to fire while connected to a patient.The customer confirm that there is no harm associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has 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
Based on the investigation and per sample sent by the customer vyaire determined that personnel may be related with the reported defect since if they do not follow the instructions indicated on spm 71-14249 etal on the correct manufacture of the part number 8023hp, they could damage the wire during the molding process of the cap, since if the wire is not properly placed inside the mold, the wire could be trapped for the molds and damage to the plastic surface may occur exposing the wire.Therefore the rot cause was determined.In addition pfmea 07d was reviewed and we have the controls for this kind of issues.As corrective and preventive action, personnel were retrained on spm 71-14249 etal highlighting the correct molding process for the wire.Also personnel were notified about the complaint.

• Brand Name: INSPIRATORY LINE HTD 8FT ADULT 20/CS
• Common Device Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• 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 produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13025437
• Report Number: 8030673-2021-00222
• Device Sequence Number: 1893816
• Product Code: BZE
• UDI-Device Identifier: 10885403039539
• UDI-Public: (01)10885403039539
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K993833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: Lay User/Patient
• Device Model Number: INSPIRATORY LINE HTD 8FT ADULT 20/CS
• Device Catalogue Number: 4681-504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 04/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown