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

Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This information was not provided by the customer.Ge healthcare's investigation is ongoing at this time.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that the cscs v1 was not audibly alarming.The visual alarms were still present.There was no related adverse patient impact.
Additional Manufacturer Narrative
On follow-up, the customer confirmed there was no related patient harm and that the alarms at the bedside monitor were still present and intact.The customer removed the cscs v1 from patient use but could no longer locate it.Therefore, the cscs v1 and its log files were not available for ge healthcare evaluation and analysis.In a historical data review, gehc did not identify any adverse trend associated with the reported issue.Based on the limited information available, a definitive root cause could not be determined.

• 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: 19269804
• Report Number: 3008729547-2024-00006
• Device Sequence Number: 6996878
• Product Code: DXJ
• UDI-Device Identifier: 00840682109826
• UDI-Public: 010084068210982611161021
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024
• 2 Devices were Involved in the Event: 1 2

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
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2016
• 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
• Patient Sex: Unknown