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

Model Number	E
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were flames from the back of the system where the power connector goes into the system.The flames stopped right after the unit was unplugged.There was no need for an extinguisher.There were no injuries reported.
Additional Manufacturer Narrative
Legal manufacturer: hcs wuxi - no.19 changjiang road national hi-tech dev.Zone china wuxi jiangsu, 214028.D2 common device name: 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
H3: ge healthcares investigation has been completed.The logiq e r7 system receives power through a docking cart connector when mounted.A short-circuit occurred between the dc 20v and ground pins on the docking connector, resulting in burn marks on both the cart connector and the logiq e console receptacle.No design or manufacturing defects were found, but signs of liquid residue and dust were observed near the affected area.The short-circuit was attributed to conductive liquid ingress into the connector, not to mechanical damage or misalignment, as positioning pins remained intact and undamaged.Although the customer reported a broken handle and suspected it caused an arc, simulation tests confirmed that the systems design prevents tilting or loose connections.The root cause was determined to be environmental contamination, specifically liquid intrusion, and not a failure of gehc product design or quality.No further actions are planned by gehc.

• Brand Name: LOGIQ
• 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: 22710060
• Report Number: 9710602-2025-02670
• Device Sequence Number: 21124397
• Product Code: IYN
• UDI-Device Identifier: 00840682103855
• UDI-Public: (01)00840682103855(11)171212
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: E
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2017
• 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