MAUDE Adverse Event Report: VYAIRE MEDICAL PATIENT CIRCUIT, W/O PEEP, 15MM, SPU, SINGLE HEATED WIRE, F&P; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number	M2M ASSY,10PK,SGL HTD CIRC,SPU,PED
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, it was confirmed that the humidifier showed f2 alarm after installing the defective circuit while being used in a patient.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 15090-104 - m2m assy,10pk,sgl htd circ,spu,ped had defective heated wire circuit.The circuit also caused heaters to blow fuses.This happened during patient use.The circuit and heater was replaced and the customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: PATIENT CIRCUIT, W/O PEEP, 15MM, SPU, SINGLE HEATED WIRE, F&P
• Common Device Name: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• 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: 15568322
• Report Number: 8030673-2022-00273
• Device Sequence Number: 2781075
• Product Code: CBK
• UDI-Device Identifier: 10190752117990
• UDI-Public: (01)10190752117990(10)0004161386
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: M2M ASSY,10PK,SGL HTD CIRC,SPU,PED
• Device Catalogue Number: 15090-104
• Device Lot Number: 0004161386
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/07/2022
• 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