MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MONITOR,BP,AUTO,DIGITAL,ADULT & LG A

Catalog Number	MDS4001PLUS
Medical Device Problem Codes	Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "1 of the 2 units is not working" and "a couple days ago, there was an error message, but they can't remember what it was.Now, it won't even start." she said, "it wouldn¿t attempt to blow any air into the cuff.It does not do anything now.".
Additional Manufacturer Narrative
The customer reported that 1 of the 2 units is not working, there was an error message but they can't remember what it was, and now it won't even start.Medline received 1 medline digital blood pressure monitor with two cuffs and tested the monitor with 4 new aa batteries according to the instructions for use; after pressing the start/stop button, there were no indications of functionality, the set and mem buttons did not perform as intended, and a visual internal inspection revealed no manufacturing defects.The complaint was confirmed.The issue shown via investigation was caused by a functional malfunction not allowing the unit to turn on properly after the start/stop button has been pressed, and the sample did not work as intended.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: DBD-MONITOR,BP,AUTO,DIGITAL,ADULT & LG A
• 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: 50840886
• Report Number: 1417592-2026-46233
• Device Sequence Number: 16021876
• Product Code: DXN
• UDI-Device Identifier: 00888277362089
• UDI-Public: 00888277362089
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193627
• 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): 09/18/2026

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: MDS4001PLUS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2023
• 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: 12/04/2023
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown