MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PUMP,REPLACEMENT,APP,AIRONE,ADJUSTABLE

Catalog Number	MSCAOPUMPADJ
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, it was discovered that the air mattress had "melted onto the bed mattress".The customer reported that the end-user was using the bed in their facility for "2-6 months".The customer reported that they are unable to identify the cause of the melt.The customer reported that there was no injury as a result of the reported product problem.The customer reported that there was no follow-up care, medical, and/or surgical intervention or treatment required.No additional details are available related to the customer reported issue.No medical intervention, serious injury, or follow-up care has been reported.
Event or Problem Description
According to the customer, it was discovered that the air mattress had "melted onto the bed mattress".

• Brand Name: MEDLINE
• Common Device Name: PUMP,REPLACEMENT,APP,AIRONE,ADJUSTABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sara young ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24809302
• Report Number: 1417592-2026-00376
• Device Sequence Number: 10682853
• Product Code: FNM
• UDI-Device Identifier: 10080196404001
• UDI-Public: 10080196404001
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Lay User/Patient
• Device Catalogue Number: MSCAOPUMPADJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White