MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MONITOR,BP,AUTO,DIGITAL,ADULT

Catalog Number	MDS4001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "readings are not lining up with doctor's.".
Additional Manufacturer Narrative
The reported issue was readings off, and the complaint transcript states, "readings are not lining up with doctor's"; the customer also stated, "i have to check my blood pressure three times due to my quadriple bypass." medline received 1 ea automatic digital blood pressure monitor; upon visual inspection there were no noticeable defects or cosmetic damage, and functional testing was performed by simulating blood pressure at 120/80 @ 80bpm and 150/100 @ 80bpm, with noted values of 118/80 @ 80bpm and 148/101 @ 78bpm.These are within acceptable ranges, and the complaint was not confirmed.No root cause was identified; no further action was taken because objectionable trends were not seen for this issue, and the division will continue to monitor trends.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: DBD-MONITOR,BP,AUTO,DIGITAL,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946439
• Report Number: 1417592-2026-54258
• Device Sequence Number: 21215938
• Product Code: DXN
• UDI-Device Identifier: 00888277361228
• UDI-Public: 00888277361228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193627
• 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: MDS4001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2024
• 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: 02/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown