MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ALARM,TAMP-RESISTANT,DUAL PADS,EA

Catalog Number	MDT8520T
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Skin Tears (2516); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "alarm not sounding when patients move/ try to get out of bed.".
Additional Manufacturer Narrative
The customer reported "our branded bed alarms not going off when patients try to get up"; additional facility information stated the patient was found on knees in the bathroom, the patient had no injuries, and the medline box was not alarming.Medline received one alarm in used condition without batteries, did not receive the sensor pad the customer was using, inserted known working batteries, and tested the alarm with a known working sensor pad; the alarm functioned properly and rang when pressure was lifted off the pad, and both sensor pad ports functioned properly.The customer complaint was not confirmed.It is most likely that the batteries the customer had in the alarm were dead and no longer working, and 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: ALARM,TAMP-RESISTANT,DUAL PADS,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913533
• Report Number: 1417592-2026-51807
• Device Sequence Number: 12206935
• Product Code: KMI
• UDI-Device Identifier: 10193489001648
• UDI-Public: 10193489001648
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/25/2026

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: MDT8520T
• Device Lot Number: 75723070002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2025
• 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: 01/24/2025
• Initial Report FDA Received Date: 09/28/2026
• 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