MAUDE Adverse Event Report: VYAIRE MEDICAL HUMIDIFIER KIT 500ML 12/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	HUMIDIFIER KIT 500ML 12/CS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
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.Device not returned yet.
Event or Problem Description
The customer reported to vyaire medical the humidifier kit 500ml 12/cs sterile water inhalation was not bubbling properly during patient use, and started to spout sterile water from the top due to increase pressure.The customer confirmed no harm was done to the patient.
Additional Manufacturer Narrative
Result of investigation: the suspect device was not returned for evaluation.The dhr review of lot number tl2207052 was performed in order to demonstrate that the lot was manufactured in accordance with established procedures and production controls.In addition, the packaging statistical inspection results meet the acceptable criteria.The samples inspection consisted in the adhesive label information evaluation where the information capture was correct according to the material number and lot number.In addition, the humidifier shape, adapter, conditions that could compromise bottle quality were visually and physically inspected.No bottle leaks connector problems were detected.Based on the aforementioned, it was determined that manufacturing process was not identified as a failure mode.

• Brand Name: HUMIDIFIER KIT 500ML 12/CS
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA ; s.a. de c.v. carretera san isi; dro mazatepec # 7000 tlajomulc; jalisco ; MX
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15838067
• Report Number: 3013421741-2022-00023
• Device Sequence Number: 17666334
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2207052
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K853146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 2620
• Device Lot Number: TL2207052
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 04/05/2023
• 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
• Patient Sex: Unknown