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

Catalog Number	MDS1001
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that "digital blood pressure is reading up and down and not giving a reading accuracy.Tried to leave on longer and adjusted the cuff but still not working.Does not show no error code.".
Additional Manufacturer Narrative
The customer reported receiving a medline bp monitor that is inaccurate and reported that the blood pressure cuff would inflate and did not stop, no error code was displayed, and no injury occurred or medical intervention was required.At this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, 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 not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo; the listed cause was "sample required to determine cause." no trends were identified for the specified material number and its corresponding defect type, the division will continue to monitor trends, 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: DBD-MONITOR, BP, AUTO, DIGITAL, ADULT
• 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: 50884940
• Report Number: 1417592-2026-50099
• Device Sequence Number: 10707915
• 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): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MDS1001
• Device Lot Number: L200580005
• 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: 03/13/2026
• Initial Report FDA Received Date: 09/24/2026
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 220 LB