MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,HYDRAULIC,6 POINT CRADLE

Catalog Number	MDS88200D
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the lift valve is closed and its not pumping up.¿ it was also reported that ¿the replacement hydraulic cylinder received in not exactly the same,¿ ¿this one does not seem to pump up high enough,¿ and ¿with the lever released, it does not drop the boom arm.¿.
Additional Manufacturer Narrative
The customer reported that the lift will not go up and the valve is closed; later, the customer stated that the replacement hydraulic cylinder received in not exactly the same, this one does not seem to pump up high enough, and with the lever released, it does not drop the boom arm; the complaint states the issue did not occur during use and no injury occurred.Medline reviewed photo evidence provided by the customer; a physical sample was not provided, and a functional or dimensional inspection cannot be executed via a photo.Investigation results were ¿confirmed bent boom, not confirmed leaking cylinder¿; after reviewing the photo, the boom arm appears to be severely bent downward, while the customer did not provide a photo or the sample of the original hydraulic cylinder.The root cause of this issue is unknown due to the lack of information provided by the customer; the investigation concluded it is likely that there was no issue with the hydraulic cylinder, but due to the damage to the boom, the customer was unable to raise and lower the lift to its usual height, 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,HYDRAULIC,6 POINT CRADLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948768
• Report Number: 1417592-2026-54664
• Device Sequence Number: 9624465
• Product Code: FSA
• UDI-Device Identifier: 40080196764250
• UDI-Public: 40080196764250
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/29/2026

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: MDS88200D
• Was Device Available for Evaluation?: Yes
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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