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

Catalog Number	MDS1001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "numbers go up and down.It over inflates - extreme pressure on my arm where i have to press the stop button.".
Additional Manufacturer Narrative
The customer reported the medline bp machine was malfunctioning; numbers go up and down, and it over inflates with extreme pressure on the customer's arm where the stop button had to be pressed.The investigation documented that the issue was requested to be closed by the customer, having resolved the issue on their own, and the review of the last three sop-00032 trend reports found no trends for the specified material number and its corresponding defect type.The defect was documented as an unconfirmed defect, with sample required to determine cause.No new information, failure modes, or trends were identified, and no additional investigation is required unless a sample, photo, and/or additional information becomes available.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: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913444
• Report Number: 1417592-2026-51802
• Device Sequence Number: 12110922
• Product Code: DXN
• UDI-Device Identifier: 00888277629656
• UDI-Public: 00888277629656
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/25/2026

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: MDS1001
• 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: 07/21/2023
• Initial Report FDA Received Date: 09/28/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown