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

Catalog Number	MDS4001PLUS
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	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bp machine is not providing accurate readings.Per the customer the machine is providing the same readings for multiple individuals (all in the 130 range).
Additional Manufacturer Narrative
The customer reports the bp machine is not providing accurate readings and the machine is providing the same readings for multiple individuals (all in the 130 range).The sample was received in used condition, came with 4 aa batteries, and was tested using a fluke bp pump with measurements at 120/80 at 80 bpm and 150/100 at 80 bpm; results were 119/79 at 79 bpm and 149/102 at 79 bpm.The complaint was not confirmed, and results showed no indications of readings out of range, as the readings were within acceptance criteria of 5+/- mmhg.No definitive root cause was identified; the readings off issue may be caused by placing the cuff incorrectly or not following the operational instructions properly, and the monitor 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: DBD-MONITOR,BP,AUTO,DIGITAL,ADULT & LG A
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858199
• Report Number: 1417592-2026-48077
• Device Sequence Number: 13246004
• Product Code: DXN
• UDI-Device Identifier: 00888277362089
• UDI-Public: 00888277362089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/22/2026

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: MDS4001PLUS
• Device Lot Number: L230280004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2023
• 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: 12/01/2023
• 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