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

Catalog Number	MDS5001
Medical Device Problem Codes	Computer Software Problem (1112); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device "wouldnt even start, keeps giving er0, tried several times.".
Additional Manufacturer Narrative
The customer reported receiving a medline bp monitor that was giving an error message during use, with "keeps giving er0" reported at the time of the complaint.Medline received the auto bp monitor in used condition, inserted control batteries, tested the sample according to the instructions for use, repeated the same procedure using a control cuff and new batteries, and performed a visual inspection.The complaint was confirmed; the monitor turned on and attempted to inflate the cuff; however, no readings were shown and an "error u" was displayed at the end.No manufacturing issues preventing the unit from working properly were seen, the cause could not be determined with the received sample, the vendor was notified, 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,UNIVERSAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50952336
• Report Number: 1417592-2026-55117
• Device Sequence Number: 18529707
• Product Code: DXN
• UDI-Device Identifier: 00888277675714
• UDI-Public: 00888277675714
• 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): 09/29/2026

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: MDS5001
• Device Lot Number: L250480006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2025
• 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: 09/19/2025
• 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