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

Catalog Number	MDS4003
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Other
Event or Problem Description
It was reported that the blood pressure monitor is reading too high.It is not reading accurately right away.
Additional Manufacturer Narrative
The reporter stated the blood pressure monitor is reading too high and mb followed set up procedure out of box and it is not reading accurately right away.Medline received 1ea wrist bp monitor in used condition, inserted 2 aaa control batteries, and tested the sample according to the instructions for use; the bp monitor was received in kpa measuring mode and was changed to mmhg measuring mode for testing, with results of 120/82 at 80 bpm and 152/101 at 80 bpm.The complaint was not confirmed, and the cause was documented as unconfirmed defect - not confirmed with received sample.Results showed no indications of readings out of range, there was no indication of any malfunctions or power issues, and the sample worked 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: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946514
• Report Number: 1417592-2026-54278
• Device Sequence Number: 10451995
• Product Code: DXN
• UDI-Device Identifier: 00888277675493
• UDI-Public: 00888277675493
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122482
• 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): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MDS4003
• Device Lot Number: 07523090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2024
• 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: 04/04/2024
• Initial Report FDA Received Date: 09/30/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown