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

Catalog Number	MDS3001U
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "customer explained that the unit is providing inaccurate pulse readings and high readings in general.His health nurses come often and told him this is wrong.".
Additional Manufacturer Narrative
The report states, "customer explained that the unit is providing inaccurate pulse readings and high readings in general.His health nurses come often and told him this is wrong." due diligence has been completed.Despite good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: MONITOR,BP,AUTO,DIGITAL,UNIVERSAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945225
• Report Number: 1417592-2026-54040
• Device Sequence Number: 10429525
• Product Code: DXN
• UDI-Device Identifier: 00888277408626
• UDI-Public: 00888277408626
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/30/2026

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: MDS3001U
• 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: 09/14/2026
• 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