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

Catalog Number	MDT8520T
Medical Device Problem Codes	Defective Alarm (1014); Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the bed alarms was fully connected to the nurse call system; the alarm pad and the battery were full of charge.But it didn't work, no matter if we pressed the side button or reconnect.The other works, but it keeps sending messages to the nurse call system as it is disconnected.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.
Additional Manufacturer Narrative
It was reported that one of the bed alarms was fully connected to the nurse call system; the alarm pad and the battery were full of charge.But it didn't work, no matter if we pressed the side button or reconnect.The other works, but it keeps sending messages to the nurse call system as it is disconnected.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.

• Brand Name: MEDLINE
• Common Device Name: ALARM, TAMP-RESISTANT,DUAL PADS,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes dr; northfield IL 60093 -275
• Manufacturer Contact: shelena smoke-wyche ; three lakes dr; northfield, IL 60093--275
• MDR Report Key: 50869436
• Report Number: 1417592-2026-10335
• Device Sequence Number: 21511715
• Product Code: KMI
• UDI-Device Identifier: 10193489001648
• UDI-Public: 10193489001648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Number: MDT8520T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown