MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. REVOLUTION; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	ACE
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained an elbow fracture when their arm (which was not secured with patient straps) moved off the table and struck the gantry while the table was moving into the bore.There is no indication of device malfunction.
Additional Manufacturer Narrative
Legal manufacturer: hcs beijing - west area of building no.3, no.1 yongchang north road, beijing economic and technological development area china beijing, 100176 ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
Block a: patient information was not obtained due to country privacy laws.A 70 y/o female patient with a cerebral infarction and no sensation in her left limb was undergoing a lung scan.The technologist did not use patient positioning straps and instructed the patient to raise her arms for the scan.After the scan completed, the unsecured patient's left arm slipped off the table and contacted the gantry while the table was moving.The patient called out for help and the technician stopped the table.After the incident there was no bleeding or visible trauma observed.A day later the patient's left hand was swollen, and a subsequent x-ray revealed a left elbow fracture.Symptomatic treatment was provided and after a week of hospitalization the patient was discharged.Investigation concluded there was no malfunction of the system and the root cause was determined to be unintended user error, i.E.The patient was not kept sufficiently still during scanning.The user manual (p/n 5808971-1en rev 6) provides instructions on appropriate patient positioning."keep the patient in view at all times.Keep patient's extremities away from surrounding equipment." the design's residual risk has been determined to be afap and no mitigations are available to significantly reduce the risk further.Gehc will continue to trend similar events.

• Brand Name: REVOLUTION
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; bld 3 1 yongchang north road; beijing economic and tech; beijing 10017 6; CH 100176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; bld 3 1 yongchang north road; beijing economic and tech; beijing 10017 6; CH 100176
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 20641460
• Report Number: 9613445-2024-00005
• Device Sequence Number: 17997700
• Product Code: JAK
• UDI-Device Identifier: 00840682146159
• UDI-Public: (01)00840682146159(11)200713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192686
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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
• Device Model Number: ACE
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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: Other
• Patient Sex: Unknown