MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML.; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	HUMIDIFIER KIT 500ML 12/CS
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
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.Also, the issue happened with three lot numbers.Please see (b)(4).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 during use, the hospital staff noticed that the (b)(6) - humidifier kit 500ml 12/cs was easily disengaged from the oxygen gauge.They also observed that it constantly alarms, and the pressure is building up inside the bottle, which causes it to expand or bloat.Upon inspection, they noticed that the oxygen port opening was too small.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 and h10.The origin of the finding that generates the low yield affectation in lot tl2205041 is attributed to the increase in rejections due to the covered pivot in the conditioning stage.This increase has a multifactorial root cause: "equipment." since there were constant stoppages due to malformation, despite the fact that this defect is easy to segregate due to its visual evidence, there is a possibility that some parts were sterilized with the "covered pivot" defect because the backpressure test is performed every 2 hours according to what is established in the bmr.That is why it is also attributed to the "method," since there is no reference to the frequency of the backpressure test when the equipment presents failures due to malformation.Based on the above, the non-functional parts were discarded from the process and classified as nonconforming products.The physicochemical and microbiological results of the parts in good condition comply satisfactorily with the established specifications.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 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: 18361408
• Report Number: 3013421741-2023-00053
• Device Sequence Number: 15377874
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2205041
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 2620
• Device Lot Number: TL2205041
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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