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

Catalog Number	MDT8450Y
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that alarm caught on fire.
Additional Manufacturer Narrative
The customer reported that the alarm caught on fire and the facility reported that on (b)(6) 2023 a staff member came into a patient¿s room and smelled an odor and heard a buzzing sound; the alarm device was found on the night stand with visible damage to the device, with no visualized smoke, fire, or spark and no patient involvement or injury noted.Medline received one patient alarm in used condition and observed that the front of the casing had a visible burn hole through which the internal circuitry was visible, the battery hatch was intact, the battery was still in the unit, and the unit had a very strong odor of burnt plastic.The investigation results were confirmed; the product was inspected per pic-00394 and the result of the pic testing was functional defect.The cause was documented as cannot determine cause with received sample, 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 RES,NURSE CALL,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803128
• Report Number: 1417592-2026-43414
• Device Sequence Number: 12910707
• Product Code: KMI
• UDI-Device Identifier: 10888277675209
• UDI-Public: 10888277675209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/16/2026

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: 03522100001
• 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: 05/01/2023
• Initial Report FDA Received Date: 09/17/2026
• 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