MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ STERILE WATER FOR INHALATION, USP 2000 ML; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	WATER STERILE F/INHALATION 2000ML 6/CS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer indicated that the suspect sample was not available for evaluation.Also, the issue happened with six patients.Please see (b)(6).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not available for evaluation.
Event or Problem Description
It was reported to vyaire medical that there was residue found or left in the (b)(6) - water sterile f/inhalation 2000ml 6/cs water chamber during patient use.It was also mentioned that the residue was found to range anywhere from 6¿28 days of use with the water chamber.The patients all remained stable with no adverse effects.
Additional Manufacturer Narrative
Correction: h5: corrected labeled for singe use h5 was updated to indicate correct labeled for single use information.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP 2000 ML
• 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 45645 ; MX 45645
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18062181
• Report Number: 3013421741-2023-00040
• Device Sequence Number: 20700102
• Product Code: BTT
• UDI-Device Identifier: 10190752196438
• UDI-Public: (01)10190752196438
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: WATER STERILE F/INHALATION 2000ML 6/CS
• Device Catalogue Number: 2D0737
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 07/15/2024
• 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
• Patient Sex: Unknown