MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR,BP,WRIST,DIGITAL UNIT

Catalog Number	MDS3003
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it was not giving them the proper reading.It was giving them error" and "one of of the error that it is shows is error 4.".
Additional Manufacturer Narrative
The customer reported that the bp was "not giving them the proper reading," was "giving them error," and one error "is error 4." medline received 1ea wrist bp monitor in used condition; the sample came with 2 aaa batteries, 2 aaa control batteries were inserted and the sample was tested according to the instructions for use, and the sample turned on and would inflate the cuff; however, the monitor would then display "er 4." medline changed the cuff and then attempted to perform several consecutive blood pressure measurements, but the issue continued; the complaint was confirmed, and the issue shown via investigation was caused due to a functional malfunction, not allowing the monitor to inflate the cuff properly.Cause was documented as "cannot determine cause w/received sample," and the sample did not operate as intended.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,WRIST,DIGITAL UNIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856722
• Report Number: 1417592-2026-47936
• Device Sequence Number: 9652064
• Product Code: DXN
• UDI-Device Identifier: 10080196525188
• UDI-Public: 10080196525188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183535
• 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): 09/22/2026

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: MDS3003
• Device Lot Number: 43324010004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2024
• 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: 04/02/2024
• Initial Report FDA Received Date: 09/22/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown