MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. CARESCAPE B650; MONITOR, PHYSIOLOGICAL, PATIENT

Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2025
Type of Reportable Event	Death
Event or Problem Description
A patient was being monitored with the carescape b650 when it was reported that the patient was found in asystole, but the device was not alarming as expected.The patient did not survive.
Additional Manufacturer Narrative
Legal manufacturer: gehc trout, 3114 n grandview blvd.Waukesha, wi 53188 usa.Ge healthcare's investigation is in-progress.A supplemental report will be submitted when the investigation is completed.
Additional Manufacturer Narrative
Ge healthcare has completed its investigation.Engineering reviewed the monitor log files and found that multiple alarms were provided for the event.A medium-priority brady alarm was asserted followed by a leads off condition alarm (also as medium-priority level).At medium-priority, the monitor provides both visual and audible notifications.The leads off alarm is given when the ecg electrodes or leads are detected as disconnected from the patient.It is intended to alert the user and prompt the appropriate troubleshooting measures.The logs showed that once ecg leads connection was restored, the monitor asserted multiple asystole alarms which were acknowledged by the users.The ge healthcare field engineer tested the device with a simulator and confirmed it was alarming as specified.In a review of historical data, no adverse trends were identified.Based on the information available, the investigation concluded that the monitor was working as designed.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: CARESCAPE B650
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT
• 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: 23849803
• Report Number: 3008729547-2025-00106
• Device Sequence Number: 10030186
• Product Code: MHX
• UDI-Device Identifier: 00840682105200
• UDI-Public: (01)00840682105200(11)190903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131223
• 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): 03/11/2026

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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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