MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) LOGIQ E; SEE H11

Model Number	ULOGEE
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a procedure in the operating room (or) and while staff was moving equipment within the or, the ultrasound system was unplugged from the wall when it was noticed that the battery began to smoke and spark.The anesthesia technologist removed the battery from the system which halted the sparking.The patient was still in the room at the time of the incident, but the system was not in use on the patient.No injuries were reported.
Additional Manufacturer Narrative
Legal manufacturer: hcs wuxi - no.19 changjiang road national hi-tech dev.Zone china wuxi jiangsu, 214028.D2: system, imaging, pulsed doppler, ultrasonic.H3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
B4: g1, 3, 6; h2, 3, 6.H3: ge healthcare has concluded its investigation.The system's exterior was clean, showing no signs of overheating, impact, or being dropped.Minor thermal damage was found in the battery compartment at the bottom of the system, which aligns with its proximity to the battery incident.The battery cell itself showed evidence of thermal damage.No clear signs of electrical faults or short circuits were found inside the system or on the battery board.The controller chip was damaged when the system was submerged in water by the customer, preventing access to battery health data.No defects were identified in gehc's products or manufacturing processes.At the time of installation, all manufacturing tests including battery functionality were completed successfully with no issues detected.Based on typical usage of one cycle per day, battery replacement is recommended every three years.Annual battery maintenance is advised, as outlined in the service manual.The product that this occurred was part of a communication regarding age and end of service life.Based on the investigation, the likely root cause of the issue is increased battery cell impedance, potentially due to aging and lack of regular recommended maintenance by the customer on a system being used beyond the communication of end of service life.

• Brand Name: LOGIQ E
• Common Device Name: SEE H11
• 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: karen hoffman ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226
• MDR Report Key: 21522630
• Report Number: 9710602-2025-00337
• Device Sequence Number: 13189904
• Product Code: IYN
• UDI-Device Identifier: 00840682103855
• UDI-Public: (01)00840682103855(11)140424
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

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
• Device Model Number: ULOGEE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2014
• 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