MAUDE Adverse Event Report: ICU MEDICAL, INC. COGENT HEMODYNAMIC MONITORING SYSTEM; OXIMETER

Catalog Number	58400-000
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the tablet not showing values was confirmed on the returned sample.The device failed visual inspection with a swollen battery.The device was unable to be charged through an external source and the display was not shown.The probable cause of the battery not able to be charged and no display had occurred due to a dead battery.
Event or Problem Description
The original event occurred on an unspecified date and involved a cogent where it was reported the base isn't showing certain values, and tsh900411 for the screen which is not booting up with error.The device was returned for investigation and the complaint was confirmed of the tablet not showing values.The device failed visual inspection with a swollen battery.The device was unable to be charged through an external source and the display was not shown.The probable cause of the battery not able to be charged and no display had occurred due to a dead battery.There was not patient involvement and no patient harm reported.

• Brand Name: COGENT HEMODYNAMIC MONITORING SYSTEM
• Common Device Name: OXIMETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19816640
• Report Number: 1713468-2024-00003
• Device Sequence Number: 8589324
• Product Code: DXG
• UDI-Device Identifier: 00840619099459
• UDI-Public: (01)00840619099459(11)200924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152006
• 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
• Report Date (Section B): 07/24/2024

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: 58400-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown