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U.S. Department of Health and Human Services

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

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Medline Industries, LP MEDLINE; BED, BASIC, FULL ELECTRIC, 450 LB Back to Search Results
Catalog Number MDR107003E
Medical Device Problem Code Damaged Thread (4075)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/05/2023
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the head section will not raise and makes a grinding noise.
 
Additional Manufacturer Narrative
The technician states that the head of the bed is not going up and believes it is something with the actuator; the customer stated that the foot section and hi-lo function properly.Medline received one bed "motor only" in used condition, and when tested the head actuator is making a skipping sound and is slow/weak; the leg actuator and the hi-lo function does work ok.The investigation results were confirmed, and the result of the pic testing was functional defect; the cause was documented as cannot determine cause w/received sample.No other damage is visible to the case, power cord, or plug end, 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.
 
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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
sullivan bluhm
three lakes drive
northfield, IL 60093--275
MDR Report Key50933909
Report Number1417592-2026-53297
Device Sequence Number13195252
Product Code LLI
UDI-Device Identifier40080196321002
UDI-Public40080196321002
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Type of Report Initial
Report Date (Section B) 09/23/2026
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 NumberMDR107003E
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2023
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 05/05/2023
Initial Report FDA Received Date09/29/2026
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 Number1
Patient SexUnknown
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