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

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

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 Description

It was reported to vyaire medical that during use, the hospital staff noticed that the 002620 - 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.

Manufacturer Narrative

Due to the unavailability of photographs, specific quantities of the affected material, and samples available for evaluation, it is not possible to determine the root cause of the event.The results of the functional tests, pivot opening, tightness, thickness monitoring, bottle seal diameter and thickness monitoring, backpressure opening, and statistical inspections by stage, as well as each of the rejections due to defective items identified and segregated during product manufacturing, are available.Test results comply with validated parameters and product specifications.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML.
• Type of Device: 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: 18361414
• MDR Text Key: 330971550
• Report Number: 3013421741-2023-00054
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2302015
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 002620
• Device Lot Number: TL2302015
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1