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

Model Number	MDS1001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "he can hear a hissing sound coming from the cuff and not getting accurate reading.There is an error message coming from the machine.".
Additional Manufacturer Narrative
The customer reported that he could hear a hissing sound coming from the cuff, was not getting accurate reading, and there was an error message coming from the machine; per the customer, no one was injured or impacted.Medline received one auto bp monitor in used condition, inserted 4 aa control batteries, and tested the sample using a fluke bp pump at 120/80 at 80 bpm and 150/100 at 80 bpm; the results were 121/79 at 80 bpm and 149/101 at 79 bpm, within acceptance criteria of 5+/- mmhg.The complaint was not confirmed, and the cause was unconfirmed defect, not confirmed with received sample.The monitor worked as intended, turned on/off as normal, and the cuff was properly inflated/deflated; based on the review of the details provided, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884040
• Report Number: 1417592-2026-49933
• Device Sequence Number: 15902489
• Product Code: DXN
• UDI-Device Identifier: 00888277629656
• UDI-Public: 00888277629656
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/24/2026

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 Model Number: MDS1001
• Device Catalogue Number: S2380404292
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2025
• 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: 09/22/2025
• Initial Report FDA Received Date: 09/24/2026
• 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