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

Catalog Number	MDS400SAB
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "same as before not holding a charge/won't charge" and "the new battery pack will not charge, voltage reading is 0.".
Additional Manufacturer Narrative
The customer reported that the product was not holding a charge/won't charge and that the new battery pack will not charge, voltage reading is 0.Medline received 1 each lift part, charger, in used condition; upon opening the product, everything was intact, the cord was intact, the charger was tested in a known working volt meter and it was 27.53, and the charger's light did turn green when plugged into a known working outlet.The investigation results were not confirmed, and the customer complaint has been not confirmed.No root cause was identified; the division will monitor through trending, and there has been no change to the reportability decision associated with this complaint.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: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870708
• Report Number: 1417592-2026-49109
• Device Sequence Number: 13067370
• Product Code: FSA
• UDI-Device Identifier: 10193489019254
• UDI-Public: 10193489019254
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: MDS400SAB
• Device Lot Number: 68722062615
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2025
• 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: 01/08/2025
• Initial Report FDA Received Date: 09/23/2026
• 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