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); Electrical /Electronic Property Problem (1198); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "blood pressure machine # mds1001 that was returned by the customer as not functioning.Our technician checked and advised that the motherboard is not working just as the one before.We saw an error message on the screen which is a " 3+ ".".
Additional Manufacturer Narrative
The blood pressure machine was returned by the customer as not functioning, the technician checked and advised that the motherboard is not working, and an error message on the screen was a "3+".Samples were not received for investigation; however, photos were provided that showed the display issue reported.The complaint was confirmed; issue shown via investigation was most likely caused due to inadvertently dropping the sample onto the floor or a hard surface, damaging the screen or a functional malfunction preventing the monitor from displaying readings in its entirety.The sample did not work as intended, material trending via sap showed no similar complaints during the last 12 months, and division has 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: 50946390
• Report Number: 1417592-2026-54242
• Device Sequence Number: 9624001
• Product Code: DXN
• UDI-Device Identifier: 00888277629656
• UDI-Public: 00888277629656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2026

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: L230580005
• Was Device Available for Evaluation?: No
• 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: 01/23/2024
• 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