MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP AIRONE APP ALTERNATING PRESSURE PUMP AND PAD; SYSTEM,ALTERNATING PRESSURE PAD,ADJSTBLE

Catalog Number	MSCAIRONEADJ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction

• Brand Name: AIRONE APP ALTERNATING PRESSURE PUMP AND PAD
• Common Device Name: SYSTEM,ALTERNATING PRESSURE PAD,ADJSTBLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25896475
• Report Number: 1417592-2026-07077
• Device Sequence Number: 13299352
• Product Code: FNM
• UDI-Device Identifier: 10080196403912
• UDI-Public: 10080196403912
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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
• Device Catalogue Number: MSCAIRONEADJ
• Device Lot Number: 240915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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 Age: 70 YR
• Patient Sex: Unknown