MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ALARM,TAMP RES,NURSE CALL,EA

Catalog Number	MDT8450Y
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the alarms are no longer working.There were no reports of death, serious injury, medical intervention, or follow up care.Based on the information reviewed, the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could be likely to cause or contribute to a death or serious injury.An mdr submission was required and has been completed and documented.
Event or Problem Description
It was reported that the bed alarms are not functioning properly.

• Brand Name: MEDLINE
• Common Device Name: ALARM,TAMP RES,NURSE CALL,EA
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: melinda marquez ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25351649
• Report Number: 1417592-2026-01809
• Device Sequence Number: 10311535
• Product Code: KMI
• UDI-Device Identifier: 10888277675209
• UDI-Public: 10888277675209
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: MDT8450Y
• Device Lot Number: 03524110002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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