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

Catalog Number	MDS9400
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they read significantly higher than they should be for patients and are not interchangeable for different size patients" and "they read at least 20 higher on systolic than the person probably has".
Additional Manufacturer Narrative
The customer reported that the devices read significantly higher than they should be for patients, are not interchangeable for different size patients, and read at least 20 higher on systolic than the person probably has, resulting in extra testing and monitoring of pregnant patients.Medline received 1ea medline wall mount aneroid in like-new condition; visual inspection confirmed that all parts were attached, including the air release valve, and the sample was tested according to the instructions for use by inflating the cuff up to 300 mmhg five times with no issues experienced.The complaint was not confirmed.The cause was 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: ANEROID,WALL MOUNT,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: 50858804
• Report Number: 1417592-2026-48147
• Device Sequence Number: 15829641
• Product Code: DXQ
• UDI-Device Identifier: 30080196771268
• UDI-Public: 30080196771268
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: MDS9400
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2023
• 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: 04/17/2023
• 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