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

Catalog Number	MDS4003
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q3 2023 (july 1, 2023 through september 30, 2023).The account reported that two mds4003 wrist blood pressure monitors, identified by serial numbers (b)(6) , were displaying e1 and e4 error codes and providing inaccurate blood pressure readings during use.The customer requested replacement of both affected devices.No patient age, weight, sex, race, or ethnicity information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q3 2023 (july 1, 2023, through september 30, 2023).Associated serial numbers are (b)(6).Two mds4003 wrist blood pressure monitors were reported to display e1 and e4 error codes and provide inaccurate blood pressure readings during use.The customer reported that replacement of the batteries did not resolve the issues.No physical samples, photographs, or other supporting evidence were received for evaluation.Therefore, medline quality was unable to perform visual inspection, functional testing, or failure analysis of the reported devices.Based on the available information, the reported malfunctions could not be confirmed.There was insufficient evidence to determine whether the devices failed to meet specifications or to establish a definitive root cause.Of the events summarized, 0 devices were returned for evaluation.The devices labeled single-use status was not available, and no devices were identified as reprocessed or reused.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
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50948037
• Report Number: 1417592-2026-54543
• Device Sequence Number: 18516342
• Product Code: DXN
• UDI-Device Identifier: 00888277675493
• UDI-Public: 00888277675493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122482
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• 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: MDS4003
• 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: 07/25/2023
• 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