MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE; AIRLIFE¿ ADULT VENTURI STYLE MASK VINYL, UNDER-THE-CHIN STYLE ADULT MASK, 6 INCH

Model Number	001363
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4745: mask.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 21 cfr 803, 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 they retrieved an airlife venturi facemask package from the supply room and delivered it to the patient's (pt) room.The airlife packaging did not appear to be open but was missing the face mask and 6-inch flextube.Because the pt needed to be transported for an emergent ct and there was no time to look for a complete airlife package, a nonrebreather was used for transport.
Additional Manufacturer Narrative
H6: 4745: mask.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 "retrieved an airlife venturi facemask package from the supply room and delivered it to the patient's (pt) room.The airlife packaging did not appear to be open but was missing the face mask and 6-inch flextube.Because the pt needed to be transported for an emergent ct and there was no time to look for a complete airlife package, a nonrebreather was used for transport." regarding part 001363 was not confirmed.The root cause could possibly be a result of operator error - assembly.There have not been any 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.
Event or Problem Description
It was reported that they retrieved an airlife venturi facemask package from the supply room and delivered it to the patient's (pt) room.The airlife packaging did not appear to be open but was missing the face mask and 6-inch flextube.Because the pt needed to be transported for an emergent ct and there was no time to look for a complete airlife package, a nonrebreather was used for transport.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ ADULT VENTURI STYLE MASK VINYL, UNDER-THE-CHIN STYLE ADULT MASK, 6 INCH
• 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: 20897774
• Report Number: 8030673-2024-01037
• Device Sequence Number: 5005896
• Product Code: CAT
• UDI-Device Identifier: 10190752116689
• UDI-Public: (01)10190752116689(10)0004280881
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 001363
• Device Catalogue Number: 001363
• Device Lot Number: 0004280881
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3902560000-2024-8140
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female