MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; COMPASS UNIVERSALHG-INT

Catalog Number	CUHG1-INT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "impossible to use the device.The numbers indicating the pressure oscillate even though the device is placed flat on the work surface.".
Additional Manufacturer Narrative
The account reported finding measurement error compass, and the complaint stated that the numbers indicating the pressure oscillate even though the device is placed flat on the work surface.A photo and a sample were received for investigation; the customer provided a video for review, the received device displayed error code bf when attempting to power on indicating low battery, 10ml of water was injected through the blood channel without occlusion, and the device was connected to an external battery and subjected to pressure accuracy testing from 0-800mmhg, displaying an ability to hold pressure as well as falling within the specified range for each measurement.Based on the complaint details, video and sample evaluation, and the investigation, the complaint is confirmed; while review of the physical sample did not confirm the reported issue, the video provided by the customer does confirm the reported issue.Because the reported issue could not be confirmed with the received sample, a root cause could not be definitively identified, and the division will monitor this issue for trending purposes.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: CENTURION
• Common Device Name: COMPASS UNIVERSALHG-INT
• Manufacturer (Section D): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913228
• Report Number: 1824619-2026-00112
• Device Sequence Number: 12200682
• Product Code: DRS
• UDI-Device Identifier: 20653160290299
• UDI-Public: 20653160290299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/25/2026

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: CUHG1-INT
• Device Lot Number: 2024100490
• 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: 11/13/2025
• Initial Report FDA Received Date: 09/28/2026
• 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