MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. CSCS V1; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Medical Device Problem Codes	Device Alarm System (1012); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Legal manufacturer: gehc trout - 3114 n grandview blvd.Usa waukesha, wi 53188.A1-6: not provided by customer.Ge healthcare's investigation is on-going.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that a patient death occurred, allegedly without appropriate alarms provided by the device.
Additional Manufacturer Narrative
The customer did not provide any further clarification regarding the alleged issue.In addition, they did not provide any more details about the patient and the progression of events that led to the death.Because the customer did not notify ge healthcare until much later, the monitor log files were no longer available for analysis.In addition, the customer could not confirm the specific bedside monitor involved in the event, therefore gehc could not test it.The customer did confirm that they tested the monitor after the patient incident occurred and did not find any problems with it thus, they continued to use the monitor without notifying gehc at that time.In a review of historical data, no adverse trends were identified.Based on the limited information available, gehc was unable to determine the root cause.No further actions are planned by ge healthcare.

• Brand Name: CSCS V1
• Common Device Name: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 22338937
• Report Number: 3008729547-2025-00063
• Device Sequence Number: 9060824
• Product Code: DXJ
• UDI-Device Identifier: 00840682109826
• UDI-Public: (01)00840682109826(11)170106
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2017
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown