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	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gauge pin gets stuck in one position (at around 120~140 psi).
Additional Manufacturer Narrative
The reported issue was that the gauge pin gets stuck in one position (at around 120~140 psi).Medline received one mobile aneroid blood pressure monitor in used condition; upon visual inspection, a welch-allyn cuff was attached to the gauge, then a control medline cuff was attached and inflated up to 300 mmhg for three consecutive times with no issues experienced.The complaint was not confirmed; the sample worked as intended, and the gauge did not get stuck at any time during the inflation process.The cause code was not confirmed with received sample, and 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: ANEROID,MOBILE,ADULT CUFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50857195
• Report Number: 1417592-2026-47989
• Device Sequence Number: 9553513
• Product Code: DXQ
• UDI-Device Identifier: 40080196771333
• UDI-Public: 40080196771333
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Device Lot Number: 65123010001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2024
• 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: 07/17/2024
• Initial Report FDA Received Date: 09/22/2026
• 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