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

Catalog Number	MDS4001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this item worked one time and then stopped giving a screeen display of pulse 188 with a heart and a u with a line through it followed by the number 8.".
Additional Manufacturer Narrative
The customer stated this item worked one time and then stopped giving a screen display of pulse 188 with a heart and a u with a line through it followed by the number 8.Medline received 1 auto bp monitor in used condition; the sample came with 4 aa batteries, 4 aa control batteries were inserted, the sample did not turn on and no power signs were observed, and visual inspection found no defects of any kind.The complaint was confirmed, and installing new control batteries did not remedy the issue.Issue shown via investigation was caused by a functional malfunction; the monitor did not operate as intended, and the cause was documented as cannot determine cause with received sample.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: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948344
• Report Number: 1417592-2026-54590
• Device Sequence Number: 13374898
• Product Code: DXN
• UDI-Device Identifier: 00888277361228
• UDI-Public: 00888277361228
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/30/2026

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: MDS4001
• Device Lot Number: 230380001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2024
• 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: 12/27/2023
• Initial Report FDA Received Date: 09/30/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown