MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) B125 V1.5; MONITOR, PHYSIOLOGICAL, PATIENT

Medical Device Problem Codes	Device Alarm System (1012); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.A1-6: not provided by the 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 the monitor still displayed a "normal" ecg and spo2 when the patient was in cardiac arrest.The patient was coded but did not survive.
Additional Manufacturer Narrative
Ge healthcare (gehc) investigated by reviewing the device log files, testing the actual device involved and interviewing clinical staff.The customer did not provide any additional details about the patient.The device was tested by a gehc field engineer who found no deficiencies related to the spo2 and ecg functions.In addition, the monitor was confirmed to be alarming appropriately.Per engineering review of the log files, the monitor provided multiple alarms for the event including brady, vtach, vfib/vtac, and asystole.Based on the information available, gehc's investigation concluded that there was no indication of a device malfunction and that no further actions are needed.

• Brand Name: B125 V1.5
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: kristof soos ; 3110 n grandview blvd; milwaukee, WI 53188
• MDR Report Key: 22338911
• Report Number: 9710602-2025-02004
• Device Sequence Number: 21097393
• Product Code: MHX
• UDI-Device Identifier: 00840682138581
• UDI-Public: (01)00840682138581(11)191010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201941
• 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): 09/03/2025

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: 08/12/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2019
• 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