MAUDE Adverse Event Report: ICU MEDICAL, INC. COGENT HEMODYNAMIC MONITORING SYSTEM, REFURBISHED; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Catalog Number	58400-000R
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a cogent hemodynamic monitoring system, refurbished where the customer reported that the display does not come on- it only showed gray screen and then goes black.It was also stated that the whole unit is putting off an excessive amount of heat.This was a loaner that they received last week and was generating an excessive amount of heat.There was unknown patient involvement, unknown human harm and unknown delay of therapy.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.
Additional Manufacturer Narrative
D9: sample received on 9/7/2024.Investigation summary: the reported complaint of no display was confirmed.No visual anomalies were observed on the device.The tablet was powered on and the screen went grey on powerup.The probable cause of the grey screen is from a bad lcd screen.

• Brand Name: COGENT HEMODYNAMIC MONITORING SYSTEM, REFURBISHED
• Common Device Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20049358
• Report Number: 1713468-2024-00004
• Device Sequence Number: 20844221
• Product Code: DXG
• UDI-Device Identifier: 00887709094314
• UDI-Public: 00887709094314
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K232048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 58400-000R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown