MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUFF,BP,XL ADULT,RANGES 42-48 CM

Catalog Number	MDS9973
Medical Device Problem Codes	Inflation Problem (1310); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bp cuff is not working properly.From what i¿ve gathered from our clinical team they press start to check blood pressure and it does not trigger the cuff to tighten.".
Additional Manufacturer Narrative
The customer reported that the bp cuff is not working properly and when the clinical team press start to check blood pressure, it does not trigger the cuff to tighten.Medline received 1ea auto bp monitor and 1 ea xl adult bp cuff in like-new condition, performed testing by following the instructions for use, and the sample turned on; however, while the cuff was being inflated, the screen readings did not change from zero and then displaying error u.The complaint was confirmed, and changing the batteries and the cuff did not remedy the problem.Issue shown via investigation was caused by a functional malfunction not displaying blood pressure readings correctly; cause was documented as cannot determine cause w/received sample, and material trending showed no similar complaints during the last 12 months.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: CUFF,BP,XL ADULT,RANGES 42-48 CM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50736886
• Report Number: 1417592-2026-37299
• Device Sequence Number: 10599370
• Product Code: DXQ
• UDI-Device Identifier: 10080196721900
• UDI-Public: 10080196721900
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K233276
• 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): 09/08/2026

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: MDS9973
• Device Lot Number: 230180003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2023
• 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: 06/01/2023
• Initial Report FDA Received Date: 09/11/2026
• 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