MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLUETOOTH BP MONITOR,UNIVERSAL CUFF

Catalog Number	MDS8001B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿machine stopped working today and has a burned smell when she removed the battery but it did not looked burned.She replaced the battery and now it won't turn on at all.¿.
Additional Manufacturer Narrative
The customer reported receiving a medline bp monitor that has a burning smell/wont turn on, and there was no reported death or serious injury associated with this event.Medline received 1ea device under the description of "bp monitor burning smell, wont turn on," and upon initial inspection of the device in the battery compartment there are visible signs of corrosion on the metal connection pieces as well and a burn mark on the plastic.The complaint is confirmed; the current root cause of the defect is unknown, and the complaint was forwarded to the vendor for further investigation on retain samples of the same lot.No trends were identified for the specified material number and its corresponding defect type, and there has been no change to the reportability decision associated with this complaint.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: BLUETOOTH BP MONITOR,UNIVERSAL CUFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855310
• Report Number: 1417592-2026-47687
• Device Sequence Number: 9923518
• Product Code: DXN
• UDI-Device Identifier: 00197344077079
• UDI-Public: 00197344077079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210770
• 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): 09/22/2026

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: MDS8001B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2026
• 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: 03/25/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Female