MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR,BP,WRIST,DIGITAL UNIT

Catalog Number	MDS4003
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "item 3704/medline deluxe digital wrist blood pressure monitor is defective because the battery has died 2x in the last 2 months.She also stated that the readings are incorrect, she stated that she received a reading elsewhere that was a different number than what the wrist monitor was reporting.".
Additional Manufacturer Narrative
The reporter stated that the wrist blood pressure monitor is defective because the battery has died 2x in the last 2 months and that the readings are incorrect; she received a reading elsewhere that was a different number than what the wrist monitor was reporting.Medline received the wrist bp monitor in used condition, inserted 2 aaa control batteries, and tested the sample according to the instructions for use using a fluke bp pump; two measurements were performed and results showed no indications of readings out of range.There was no indication of any malfunctions or power issues; the monitor turned on/off as normal and the cuff was properly inflated/deflated.The complaint was not confirmed, the cause code was updated to reflect unconfirmed defect - not confirmed with received sample, and the sample 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: MONITOR,BP,WRIST,DIGITAL UNIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948709
• Report Number: 1417592-2026-54650
• Device Sequence Number: 18753629
• Product Code: DXN
• UDI-Device Identifier: 00888277675493
• UDI-Public: 00888277675493
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122482
• 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: MDS4003
• Device Lot Number: 07523030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2023
• 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: 08/16/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown