MAUDE Adverse Event Report: AIRLIFE AirLife; AirLife Adult Oxygen Mask Vinyl, Under-The-Chin Style, Medium

Model Number	001201
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction

• Brand Name: AirLife
• Common Device Name: AirLife Adult Oxygen Mask Vinyl, Under-The-Chin Style, Medium
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): Airlife; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 25787392
• Report Number: 1314417-2026-00047
• Device Sequence Number: 15859459
• Product Code: BYG
• UDI-Device Identifier: 10889483569214
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 001201
• Device Catalogue Number: 001201
• Device Lot Number: 0004311544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/01/2026
• 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