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

Catalog Number	MDS3003
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two bp moniotors reading high on all patients.When compared to other bp machines, the patient is then in a normal range for bp.
Additional Manufacturer Narrative
The reported issue was readings high on all patients; when compared to other bp machines, the patient is then in a normal range for bp.Medline received 2 ea digital wrist blood pressure monitors; upon visual inspection there was no cosmetic dammage, and during functional testing with new aaa batteries the monitors responded to all button inputs correctly and responded to simulating blood pressure at 120/80 @ 80 bpm and 150/100 @ 80 bpm.The following values were noted: monitor #1: 117/80 @ 79 bpm and 152/98 @ 79 bpm, monitor #2: 117/81 @ 80 bpm and 154/99 @ 80 bpm; these are within acceptable ranges, and the complaint was not confirmed.The cause was unconfirmed defect - not confirmed with received sample; there are currently no known trends for this product, and no further action was taken.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: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50857215
• Report Number: 1417592-2026-47991
• Device Sequence Number: 9554007
• Product Code: DXN
• UDI-Device Identifier: 10080196525188
• UDI-Public: 10080196525188
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2024
• 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: 03/07/2024
• 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