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

Catalog Number	MDS9407
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue is the unit is its measuring 5-6 mmhgs off.".
Additional Manufacturer Narrative
The customer reported receiving a medline mobile aneroid with readings off, and the complaint details stated the unit was measuring 5-6 mmhgs off.At this time, a sample(s) was not received for investigation; however, a lot number/serial number was recorded, investigation included review of recent complaint trends/scar activity for the last three trend reports, and the vendor was notified.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.Based on the available information and the fact that no physical sample has been received, it is currently not possible to accurately determine the specific cause of the abnormality; no trends were identified and there has been no change to the reportability decision associated with this complaint.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: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871838
• Report Number: 1417592-2026-49207
• Device Sequence Number: 10674091
• Product Code: DXQ
• UDI-Device Identifier: 40080196771333
• UDI-Public: 40080196771333
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/23/2026

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: 65119070002
• Was Device Available for Evaluation?: Yes
• 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: 06/06/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2019
• 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