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

Catalog Number	FCEALTMAXX
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the backup battery failed to kick in when the end user lost power.This is the first time the backup has failed.
Additional Manufacturer Narrative
Per the end user's report, the backup battery failed during the recent power outage.Medline received one battery only in used condition; upon further investigation of the sample, when tested there was no power from the battery, with no damage to the cord or plug end, and pic testing resulted in a functional defect.The investigation results were confirmed; it is possible that this may be due to an inner electrical issue, and the cause was documented as cannot determine cause with received sample.At this time the quality complaint has been confirmed, and the division will monitor through quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.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: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945480
• Report Number: 1417592-2026-54085
• Device Sequence Number: 16059526
• Product Code: OSI
• UDI-Device Identifier: 10888277651838
• UDI-Public: 10888277651838
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/28/2026

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
• Date Returned to Manufacturer: 09/15/2023
• 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: 08/25/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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