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

Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Legal manufacturer: hcs trout - 3114 n grandview blvd.Usa waukesha, wi 53188.A1-6: not provided by customer.Ge healthcare's investigation is on-going.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
While being used to monitor a patient during transport, the battery failed and the monitor shut down.It was alleged that the monitor did not alarm for low battery.The patient expired.
Additional Manufacturer Narrative
The customer did not provide any further details regarding the patient and sequence of events that occurred.Ge healthcare (gehc) reviewed the monitor log files and confirmed the monitor was providing physiological alarms until 21:05 (the customer alleged the monitor powered off at 21:15).The logs also showed the monitor was powered back on at 21:28.Gehc received the affected battery and was able to reproduce the reported issue.Following additional testing by a third-party, the gehc concluded that a rapid degradation of the battery from a single cell failure due to normal cell aging (the battery was about 5 years old) led to the unexpected power loss at the monitor.The measured remaining battery time on the monitor was greater than the alarm thresholds resulting in the monitor not having time to respond or issue an alarm before shutting off.Gehc did not identify any adverse trends related to this issue.The customer was provided with the findings.They did not express any further concerns.No further actions are planned by gehc.

• Brand Name: B125
• 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: 21894108
• Report Number: 9710602-2025-00690
• Device Sequence Number: 20857518
• Product Code: MHX
• UDI-Device Identifier: 00840682124331
• UDI-Public: (01)00840682124331(11)200923
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171580
• 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): 11/04/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 10/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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