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

Catalog Number	MDT8450Y
Medical Device Problem Codes	No Audible Alarm (1019); Premature Discharge of Battery (1057); Temperature Problem (3022)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Hematoma (1884)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's mother had fallen out of bed due to the bed alarm not functioning resulting in bruising to her back and a hematoma to the side of her hip.The customer reported that no medical intervention was needed.The customer additionally stated that the "battery was hot to the touch" and "would run out of energy quickly." a sample has been requested for evaluation.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 requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient's mother had fallen out of bed due to the bed alarm not functioning resulting in bruising to her back and a hematoma to the side of her hip.The customer reported that no medical intervention was needed.The customer additionally stated that the "battery was hot to the touch" and "would run out of energy quickly.".

• Brand Name: MEDLINE
• Common Device Name: ALARM,TAMP RES,NURSE CALL,EA
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 25205812
• Report Number: 1417592-2026-01442
• Device Sequence Number: 18650931
• Product Code: KMI
• UDI-Device Identifier: 10888277675209
• UDI-Public: 10888277675209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDT8450Y
• Device Lot Number: 44825070001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG