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 Difficult to Open or Close (2921)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3: 81 other - 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.

Event Description

It was reported to vyaire medical that when the bottle of humidifier kit 500ml 12/cs is opened on the front with a twist tab, it doesn¿t always completely open, and sometimes isn¿t obvious when it's hooked up to flow on the wall.When it's hooked up and turned on, flow doesn¿t come out the front very well.The customer tried to open the hole with a scissor and remove it from the wall, causing a water fountain of back pressure to spray all over the staff member and the room.This happens occasionally and not with all bottles.Also, the customer is unable to put more than 3 liters of flow through the system because it pops off and when disconnected, causes the fountain to occur and sprays all over the room.

• 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 ; MX
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17126507
• MDR Text Key: 317757149
• Report Number: 3013421741-2023-00034
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2208064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2023

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: 2620
• Device Lot Number: TL2208064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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