MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) B125M; MONITOR, PHYSIOLOGICAL, PATIENT

Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient monitor provided incorrect nibp readings for which the patient was unnecessarily administered medication.The patient did not sustain any injury due to the alleged unnecessary medication.
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.
Additional Manufacturer Narrative
On follow-up, the customer did not provide any additional details regarding the patient's current condition.They also indicated the nibp cuff was replaced but did not clarify further the timeline of events.The ge healthcare (gehc) field service engineer tested the device with a simulator following the incident but was unable to reproduce the alleged issue.Gehc engineering reviewed the log files and confirmed that all nibp measurements were completed without any error messages indicative of an issue with the nibp parameter function.In a review of historical data, no issues or adverse trends were identified.Based on the information available, the root could not be determined.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 gehc.

• Brand Name: B125M
• 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 ; 3114 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 23429615
• Report Number: 9710602-2025-03671
• Device Sequence Number: 8179159
• Product Code: MHX
• UDI-Device Identifier: 00195278490247
• UDI-Public: (01)00195278490247(11)241022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K242562
• 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): 02/02/2026

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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: Other
• Patient Sex: Unknown