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)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "shes changed batteries mutiple times, done all suggested things in the manual to get an accurate reading and it is still wrong.Medline monitor read 235/135 with a pulse of 9.She went to kaiser afert and had them take it and it was fine.Bp monitor is incorrect.Stated mds4003 is not measuring correct.".
Additional Manufacturer Narrative
Member stated she's changed batteries multiple times, done all suggested things in the manual to get an accurate reading and it is still wrong; the monitor read 235/135 with a pulse of 9, she went to kaiser and had them take it and it was fine, and bp monitor is incorrect.At this time, a sample(s) was not received for investigation; investigation included review of the lot/serial number and recent complaint trends for the past 3 months, and per vendor, through internal investigation, including dhr review and inspection records review, no abnormalities were found.Investigation results: not confirmed; the complaint could not be confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.Sample required to determine cause; without the sample or photo, it¿s difficult to truly identify the root use of the issue, no objectionable trends were seen, the division will continue to monitor the issue for trending, and no trends were identified for the specified material number and its corresponding defect type.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: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947460
• Report Number: 1417592-2026-54448
• Device Sequence Number: 21238596
• Product Code: DXN
• UDI-Device Identifier: 00888277675493
• UDI-Public: 00888277675493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• 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: MDS4003
• Device Lot Number: 200451923081494
• 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: 02/07/2024
• 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