MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE; AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI

Model Number	002438
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate term/code not available): nebulizer the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 10 dec 2024 has been included in the 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 is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that the patient called for assistance, extremely sob and wheezing.She asked for a mask treatment, which is administered via nebulizer.Writer attempted to administer requested medication but was unable to do so.Writer checked nebulizer components and ensured that diffuser was locked properly in place then reattempted to administer the medication.Writer unable to get flow meter above 4l.Flow meter changed out with no positive result.Entire nebulizer system changed out and plugged into o2 tank.Administration successful! flow meters tested post administration.Testing confirmed that nebulizer set (1st used) malfunctioned and change out was necessary.Pcm and attending notified of event.Malfunctioning equipment sent down to purchasing with product complaint form.
Event or Problem Description
It was reported that the patient called for assistance, extremely sob and wheezing.She asked for a mask treatment, which is administered via nebulizer.Writer attempted to administer requested medication but was unable to do so.Writer checked nebulizer components and ensured that diffuser was locked properly in place then reattempted to administer the medication.Writer unable to get flow meter above 4l.Flow meter changed out with no positive result.Entire nebulizer system changed out and plugged into o2 tank.Administration successful! flow meters tested post administration.Testing confirmed that nebulizer set (1st used) malfunctioned and change out was necessary.Pcm and attending notified of event.Malfunctioning equipment sent down to purchasing with product complaint form.
Additional Manufacturer Narrative
H6: 4756 (appropriate term/code not available): nebulizer the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 10 dec 2024 has been included in the 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 is 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 a airlife product is defective or causes serious injury.The complaint of " patient called for assistance, extremely sob and wheezing.She asked for a mask treatment, which is administered via nebulizer.Writer attempted to administer requested medication but was unable to do so.Writer checked nebulizer components and ensured that diffuser was locked properly in place then reattempted to administer the medication.Writer unable to get flow meter above 4l.Flow meter changed out with no positive result." regarding part 002438 was confirmed.The root cause was determined as "not confirmed".There have been 1 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI
• 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: 20897918
• Report Number: 8030673-2024-01038
• Device Sequence Number: 9053218
• Product Code: CAF
• UDI-Device Identifier: 10190752114869
• UDI-Public: (01)10190752114869
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 002438
• Device Catalogue Number: 002438
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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: Other
• Patient Sex: Unknown