MAUDE Adverse Event Report: Centurion Medical products, LP CENTURION; INTRA-ABDOMINAL PRESSURE MONITORING KIT

Catalog Number	CMPSN003A
Medical Device Problem Codes	Battery Problem (2885); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "3 sensors not working" and "2 sensors were dead, 1 was stuck in an error message and wouldn¿t zero".
Additional Manufacturer Narrative
The customer advised 3 sensors not working: "2 sensors were dead, 1 was stuck in an error message and wouldn¿t zero." a review of production records did not find a nonconformance noted during first article or in-process inspections; initial attempts to activate each device were unsuccessful, visual inspection found no nonconformances with the placement and soldering of the battery or the electrical leads, battery voltage was below the acceptable limit of 3.1 volts, and the device that displayed an error message powered on with an alternate battery and displayed "pf" on the lcd screen.The reported problem was confirmed: the investigation concluded each device did not function due to low battery voltage, and the "pf" error indicates the device failed the power on self check, which then rendered the device inoperable; the cause of the low battery voltage and the cause of the "pf" error could not be determined.One hundred percent of compass universal devices are subject to a final test after assembly, including verifying the battery voltage meets acceptance criteria, and production records were reviewed to find that only devices confirmed to function as intended were placed in the kit.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: INTRA-ABDOMINAL PRESSURE MONITORING KIT
• 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: 50882248
• Report Number: 1824619-2026-00095
• Device Sequence Number: 9939294
• Product Code: OEZ
• UDI-Device Identifier: 10653160338475
• UDI-Public: 10653160338475
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/23/2026

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: CMPSN003A
• Device Lot Number: 2022071890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2023
• 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: 02/24/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown