MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,ELECTRIC,600LB CAPACITY

Catalog Number	MDS600ELB
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q3 2023 ((b)(6) 2023 through (b)(6), 2023).The account reported that two mds600elb patient lifts experienced failures during use while attempting to lift residents.One lift reportedly functioned for approximately one week before exhibiting the issue, while the second lift was reported to have the same condition upon receipt.The customer stated that when the lift was raised, the actuator would begin to operate but then stop moving, despite audible motor/actuator operation.The lifts could be lowered, but the upward lifting function would intermittently fail or stop during operation, both with and without a resident in the lift.Troubleshooting confirmed that the issue persisted despite the use of multiple charged batteries and use of the control panel with the hand pendant disconnected.Replacement actuators were issued for the affected units.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q3 2023 ((b)(6), 2023 through (b)(6), 2023).Associated reported serial numbers are (b)(6)and (b)(6).Two mds600elb patient lifts were evaluated following reports that the lifts would begin to raise a resident and then stop, while the actuator could still be heard operating.The customer reported that one lift functioned for approximately one week before the issue occurred, while the second lift exhibited the same condition upon receipt.Troubleshooting determined that the issue persisted despite the use of multiple charged batteries and operation through both the hand pendant and control panel.Two returned actuators were received for evaluation; however, investigation determined that the returned components were replacement actuators (mds600sabact) that had been sent to the customer in error and were not the actual actuators associated with the reported lift failures.The received actuators were identified by serial numbers (b)(6)and (b)(6)and did not correspond to the failed components from the complaint.Because the returned devices were not the actual failed components associated with the complaint, the reported malfunction could not be confirmed.Visual and functional inspection of the returned actuators did not allow verification of the alleged failure mode for the affected lifts.Therefore, there was insufficient evidence to determine whether the reported lift components failed to meet specifications.A definitive root cause could not be established based on the available information.Replacement actuators were issued to the customer as follow-up actions.Of the events summarized, 2 replacement actuators were returned for evaluation; however, the actual failed 2 components associated with the complaint were not returned.The devices were not labeled for single use, and no devices were identified as reprocessed or reused.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,600LB CAPACITY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856012
• Report Number: 1417592-2026-47804
• Device Sequence Number: 21206717
• Product Code: FSA
• UDI-Device Identifier: 10193489019261
• UDI-Public: 10193489019261
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• 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: MDS600ELB
• 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: 08/23/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Male