MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ALTERRA MAXX UNIVERSAL BED

Catalog Number	FCEALTMAXX
Medical Device Problem Codes	Fracture (1260); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "broken motor/caster.".
Additional Manufacturer Narrative
The complaint reported "broken motor/caster," and per customer information and photos, "the control box and one of the casters is broken." medline reviewed the photos provided; one photo showed the control box installed on the bed and it appeared fractured, dented or smashed with multiple fractures, while the other photo appeared to show the casters through the framing of the bed but did not allow a clear view of the casters.The investigation results were confirmed/not confirmed: the control box issue was observed in the photo, but the issue with the casters could not be verified and no sample or additional photo of the defective product was received.Based on the review, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and there was no reported death or serious injury associated with this event.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ALTERRA MAXX UNIVERSAL BED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; three lakes drive, IL 60093--275
• MDR Report Key: 50870257
• Report Number: 1417592-2026-49035
• Device Sequence Number: 10716071
• Product Code: OSI
• UDI-Device Identifier: 10888277651838
• UDI-Public: 10888277651838
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: FCEALTMAXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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 Sex: Unknown