MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,STAND ASSIST,ELECTRC,40

Catalog Number	MDS400SAB
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the lift is full charged it will not go up or down" and "maintenace thinks it's the control box".
Additional Manufacturer Narrative
The customer reported that the lift was fully charged but would not go up or down, and maintenance thought it was the control box; during troubleshooting, the lift was unoperational, the control box clicked, the lcd lit up when attempting to use the controls, and battery voltage was noted as approximately 15-18v and fluctuating.Medline received one lift "battery only" in new condition, still in the original packaging and clean, and checked the battery with a voltmeter, which showed 25.69 volts; there was no damage to the battery outer case or the electrical terminals.The investigation results were not confirmed, and the customer complaint has not been confirmed.No root cause was identified, and the division will monitor through trending.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: LIFT,PATIENT,STAND ASSIST,ELECTRC,40
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898616
• Report Number: 1417592-2026-51021
• Device Sequence Number: 18831693
• Product Code: FSA
• UDI-Device Identifier: 10193489019254
• UDI-Public: 10193489019254
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/24/2026

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: MDS400SAB
• Device Lot Number: 68720122420
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2024
• 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: 11/12/2024
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown