MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,MOBILE,ADULT CUFF

Catalog Number	MDS9407
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "first time that this bp unit was used the hand got stuck on 240.".
Additional Manufacturer Narrative
The reported failure was that the bp unit was used and the hand got stuck on 240.Medline received the medline mobile aneroid in like-new condition; upon visual inspection of the sphygmomanometer, the needle was stuck at the 240 mark, then the gauge was calibrated using the screwdriver provided with these units and tested five times by inflating it up to 300mmhg.During this process, medline experienced no issues, the cuff inflated/deflated and normal, the gauge displayed no issues, and overall the sample worked as intended; the complaint was not confirmed.No root cause was identified, and the division has been informed and 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: ANEROID,MOBILE,ADULT CUFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867010
• Report Number: 1417592-2026-48518
• Device Sequence Number: 21138070
• Product Code: DXQ
• UDI-Device Identifier: 40080196771333
• UDI-Public: 40080196771333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• 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): 09/22/2026

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: MDS9407
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/14/2023
• 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: 06/05/2023
• Initial Report FDA Received Date: 09/23/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown