MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, LOW FULL ELECTRIC, BASIC

Catalog Number	MDR107003ELO
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "foot spring motor for hi-lo bed.When bed is raising the foot board is kicking out.".
Additional Manufacturer Narrative
The customer explained the hi/lo motor housing does not tighten to the bracket fully causing it shift when the being raised and also becuase of the shift it disconnects from the footboard gearbox.Medline received 1 each of a bed "hi lo motor only" in used condition, and the product has been inspected per pic-00371.The investigation results were confirmed; upon further investigation of the sample it was discovered that the plastic mounting holes on the motor are stripped by steel bolts, and the cause code was "cannot determine cause w/received sample." the result of the pic testing was functional defect, 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: BED, LOW FULL ELECTRIC, BASIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50888659
• Report Number: 1417592-2026-50409
• Device Sequence Number: 10754194
• Product Code: LLI
• UDI-Device Identifier: 10080196546992
• UDI-Public: 10080196546992
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/24/2026

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: MDR107003ELO
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2023
• 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: 11/15/2023
• Initial Report FDA Received Date: 09/24/2026
• 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