MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE; RESUSCITATION, ADLT W/MASK, RESV BA

Model Number	2K8004
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reservoir bag failed to inflate while being attached to high flow oxygen.Patient was admitted to the icu.
Additional Manufacturer Narrative
All information reasonably known as of 21 june 2024 has been included in this health authority report.Should additional.Information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
Reservoir bag failed to inflate while being attached to high flow oxygen.Patient was admitted to the icu.
Additional Manufacturer Narrative
All information reasonably known as of 21 june 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.Since the reported defect was not confirmed and the root cause was not established no corrective or preventive actions were taken.However, assembly personnel were notified about the complaint.

• Brand Name: AIRLIFE
• Common Device Name: RESUSCITATION, ADLT W/MASK, RESV BA
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19586649
• Report Number: 8030673-2024-01008
• Device Sequence Number: 7195252
• Product Code: NHK
• UDI-Device Identifier: 10190752114104
• UDI-Public: 10190752114104
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2K8004
• Device Catalogue Number: 2K8004
• Device Lot Number: 0004266354,0004266348
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown