MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED ONLY,4-MOTOR,HI/LOW,34.5W,LOCK

Catalog Number	FCE1385B
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the remote is not working, stated to raise the bed overall high/low and head/foot section will sometimes work.Customer also reported some wires are exposed.Remote will work intermittent and also stated the green wire appears to be broken off.".
Additional Manufacturer Narrative
The customer states that the remote is not working and the hi-lo and head/foot section will sometimes work, some wires are exposed, the remote will work intermittently, and the green wire also appears to be broken off.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.Investigation results were confirmed, and the bed's hand pendant appears to have frayed wires that are exposed between the cable jacket and the base of the hand pendant, with the green wire appearing to be cut off from the pendant.Given the evidence provided in the photo the root cause of this issue is unknown, 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 ONLY,4-MOTOR,HI/LOW,34.5W,LOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946539
• Report Number: 1417592-2026-54283
• Device Sequence Number: 13349278
• Product Code: FNL
• UDI-Device Identifier: 10888277100022
• UDI-Public: 10888277100022
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: FCE1385B
• 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: 07/05/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown