MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, BASIC, FULL ELECTRIC, 450 LB

Catalog Number	MDR107003E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the motor box broke and several pieces fell off and one side of the motor was hanging off the bed." it was also reported that "he heard a crack and the bed would not work by remote.".
Additional Manufacturer Narrative
The customer stated that, when the patient went to raise the head of the bed, he heard a crack and the bed would not work by remote; no injury occurred.A photo was provided, and after reviewing the photo it was discovered that part of the motor box casing appears to be completely fractured off, the head section of the motor box appears to be fractured, and the head actuator appears to be exposed due to the fracture; functionality of the motor box can not be determined with photos.Investigation results: confirmed.Given the evidence provided in the photo the root cause of this issue is unknown; the division will monitor through 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, BASIC, FULL ELECTRIC, 450 LB
• 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: 50932041
• Report Number: 1417592-2026-53004
• Device Sequence Number: 18821962
• Product Code: LLI
• UDI-Device Identifier: 40080196321002
• UDI-Public: 40080196321002
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/28/2026

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: MDR107003E
• 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: 02/22/2024
• Initial Report FDA Received Date: 09/29/2026
• 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