MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE ADULT AEROSOL MASK VINYL, UNDER-THE-CHIN STYLE

Model Number	001206
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: (appropriate health impact term/code not available): the mask was adjusted.The product involved in the report has not been returned for evaluation, additionally no photographic or videographic evidence was provided; therefore the complaint could not be confirmed.However, this is a known failure mode that is currently under investigation.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided all information reasonably known as of 24 dec 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, despite attempts to reposition the mask, it was poking the patient in the eyes for the duration of the treatment.It was additionally reported, there was no significant delay in treatment or effectiveness; however, a non-serious injury was reported.No information provided concerning patient outcome.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE ADULT AEROSOL MASK VINYL, UNDER-THE-CHIN STYLE
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): AIR LIFE; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx, mex 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23891201
• Report Number: 1314417-2025-00114
• Device Sequence Number: 18041400
• Product Code: BYG
• UDI-Device Identifier: 10889483569276
• UDI-Public: (01)10889483569276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: 001206
• 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: 11/25/2025
• Initial Report FDA Received Date: 12/24/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown