MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. CSCS V3; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.A1, a5, b2: not provided by the customer.Ge healthcare's investigation is on-going at this time.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that a patient was found unresponsive and the central station may not have audibly alarmed.The patient was transferred to the icu where they eventually expired.
Additional Manufacturer Narrative
The customer did not provide any further details regarding the patient event or the progression of events leading up to the patient's demise.The cscs v3 log files were not available for analysis.Ge healthcare reviewed the telemetry server log files which showed that an arrhythmia suspend alarm was provided at the time of the event followed by a leads fail alarm.The arrhythmia suspend alarm is an indication of ecg noise impacting monitoring conditions and the related ecg arrhythmia alarms.The arrhythmia suspend alarm was configured to low priority by the customer (the factory default setting is high priority).The fe did not identify any issues with the audio alarms when the device was inspected.In a review of historical data, no adverse trends related to this issue were identified.Ge healthcare was unable to confirm any malfunction of the device.The risk analysis determined that no additional mitigations are available to reduce the risk, and the risk has been reduced as far as possible.No further actions are planned by ge healthcare.

• Brand Name: CSCS V3
• 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 ; 3114 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 24240085
• Report Number: 3008729547-2026-00011
• Device Sequence Number: 21075430
• Product Code: DXJ
• UDI-Device Identifier: 00195278343383
• UDI-Public: (01)00195278343383(11)250614
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2025
• 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 Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 51 KG
• Patient Race: White