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

Catalog Number	MDS400SAB
Medical Device Problem Codes	Battery Problem (2885); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the battery is being charged overight but they're getting a low battery reading," "lift has no function, is beeping and displaying low battery," and "the cord has a short.".
Additional Manufacturer Narrative
The customer stated that "the battery is being charged overight but they're getting a low battery reading," and per customer report, "lift has no function, is beeping and displaying low battery"; the customer later advised that "the cord was being unplugged wrong.So the cord has a short." the investigation documented that the sample and/or photo was not available, pcn history was reviewed with no product changes identified that could have contributed to the alleged product failure, and quality control inspection records could not be found for the serial number at that time.The investigation results were not confirmed, and the updated cause code was unconfirmed defect, sample required to determine cause.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858420
• Report Number: 1417592-2026-48101
• Device Sequence Number: 18648359
• Product Code: FSA
• UDI-Device Identifier: 10193489019254
• UDI-Public: 10193489019254
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/22/2026

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
• 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: 05/02/2024
• Initial Report FDA Received Date: 09/22/2026
• 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