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

Catalog Number	CUHG1-INT
Medical Device Problem Codes	Incorrect Measurement (1383); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new compartment syndrome kit lit up but remained stuck at an abnormal value of 134 instead of dropping back to 0 before taking the measurement.
Additional Manufacturer Narrative
Customer reported a measurement error compass: a new compartment syndrome kit lit up but remained stuck at an abnormal value of 134 instead of dropping back to 0 before taking the measurement, and the kit had not been used.Medline reviewed finished good production records and device history records; no nonconformances were found, the devices were 100% tested to confirm the devices function as intended, including a test for pressure accuracy and leaking, and no functional failures were found during final quality control testing.The returned sample would not power on; however, it was leak tested over the compass universal's pressure range and no leaking was observed, then partially disassembled and connected to a power supply, but would not hold pressure when tested at each of the test points.Given that the device held pressure during leak testing, the device was likely damaged during disassembly, and the reported issue cannot be confirmed and a root cause cannot be determined.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: 50895716
• Report Number: 1824619-2026-00105
• Device Sequence Number: 20309137
• Product Code: DRS
• UDI-Device Identifier: 20653160290299
• UDI-Public: 20653160290299
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/24/2026

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: 2025040390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2026
• 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: 12/12/2025
• Initial Report FDA Received Date: 09/25/2026
• 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