MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,ELECTRIC,400LB CAPACITY

Catalog Number	MDS400ELB
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it is not working and we escalated that issue can be on the cylinder motor.".
Additional Manufacturer Narrative
The customer reported that the lift was used for a patient, no fall or injury was reported, and the issue of the lift functioning properly was not resolved; the technician stated that the lift needs a new hydraulic cylinder or motor.Medline received 1 each of a lift "actuator & battery only" in used condition and, when bench tested with known working components, the actuator and battery did work ok as designed; the actuator fully extended and retracted with no issues from the normal sounding motor, and the battery registered at 25.72 volts and worked ok as designed in the control box.The investigation results were not confirmed, and the quality complaint has not been confirmed.A root cause could not be determined based on the available information, and the division will monitor through quarterly 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,ELECTRIC,400LB CAPACITY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855136
• Report Number: 1417592-2026-47657
• Device Sequence Number: 13149896
• Product Code: FSA
• UDI-Device Identifier: 10193489019247
• UDI-Public: 10193489019247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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: MDS400ELB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2024
• 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: 06/13/2024
• Initial Report FDA Received Date: 09/22/2026
• 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