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

Catalog Number	MDS3001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "getting error msg 4, and it is not working.".
Additional Manufacturer Narrative
Per nancy, she has had this bp monitor for some years sitting in closet and was just opening and trying to use now; the device was getting error msg 4 and it is not working.Sample sent was intended for div 35 - unable to investigate; investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 3 months, and the review of the last three sop-00032 trend reports was completed with no trends identified for the specified material number and its corresponding defect type.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, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.The cause was not identified because there were no samples, photos, videos, or other critical details provided, even after follow-ups with the customer; the division 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: MONITOR,BP,AUTO,DIGITAL,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899950
• Report Number: 1417592-2026-51212
• Device Sequence Number: 5829662
• Product Code: DXN
• UDI-Device Identifier: 10080196525140
• UDI-Public: 10080196525140
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183534
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDS3001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2023
• 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: 07/26/2023
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown