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

Catalog Number	MDS1001
Medical Device Problem Codes	Computer Software Problem (1112); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was "returned by the customer as not functioning"; "the motherboard is not working just as the one before"; and "we saw an error message on the screen which is a \" 3+ \".".
Additional Manufacturer Narrative
The customer explained that the unit was returned by a customer as not functioning, the motherboard is not working per the customer technician, and they received an error message on the screen "3+".Samples were not received for investigation; however, photos were provided that showed the display issues reported, and the vendor stated, "after checking the process of our company, we found no problems related to the process leading to complaints, but our company will record and observe the trend." the complaint was confirmed; the issue shown via investigation was caused by a functional malfunction preventing the monitor to work correctly, and the cause was documented as "cannot determine cause w/received sample." material trending via sap showed similar complaints during the last 12 months, and division and vendor have been informed and will continue to monitor trends.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
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946713
• Report Number: 1417592-2026-54319
• Device Sequence Number: 9534655
• Product Code: DXN
• UDI-Device Identifier: 00888277629656
• UDI-Public: 00888277629656
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 09/29/2026

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: MDS1001
• Device Lot Number: 230580005
• 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: 04/25/2024
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown