MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM GO.NOW; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061618

Device Problems Computer Operating System Problem (2898); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens has initiated a technical investigation of the reported event.Preliminary investigation determined that the system emergency button on the gantry box or control box had not been pushed per the associated system user manual.If the button had been pushed, the table should have been able to be pulled out manually by pulling the handle at the end of the table.The root cause of the complaint issue has not yet been identified.A supplemental report will be filed upon the completion of the investigation.(b)(6).

Event Description

It was reported to siemens that an adverse event and alleged product malfunction occurred during operation of a somatom go.Now system.The ct imaging procedure was to be performed "to" due to patient's complaint of lumbar pain.While performing the ct imaging of the patient's spine, it was reported that the ct system had stopped working.The imaging procedure was not able to be completed.The patient table could not be pulled out from the gantry.The ct operator and the patient's relative(s) removed the patient from the table without the table being pulled out of the gantry.After being removed from the table, the patient complained of thigh pain.Examination of the patient's leg revealed a femoral fracture.It is alleged that the patient's femoral fracture occurred during removal from the table.The patient was hospitalized and the fracture was treated with a cast.A second ct imaging procedure of the spine was completed using another system on the same day.The duration of the patient's hospitalization is unknown but as of november 1, 2018, it was reported that the patient has been released from the hospital.

Manufacturer Narrative

Exemption number e2017016.(b)(4) (importer) is submitting the report on behalf of siemens shanghai, medical equipment ltd., shanghai (manufacturer).Siemens has completed the investigation of the reported event.The investigation revealed that a "table top moves in" failure occurred when the user was performing top scanning of the patient.This failure was attributed to a firmware bug which affected the communication between ptab and the motor controller, or the communication with the motor controller itself.This was the root cause of the ct system stopping during imaging.The investigation has shown that the customer could resume imaging by restarting the system.This resolution was communicated to the customer.The firmware bug affecting the system was resolved by the siemens customer service engineer.As previously reported, when the system stopped working during the reported event, the user did not follow the system instructions for use for manual table movement and removed the patient from the table without the table being pulled out from the gantry.This resulted in the reported patient injury.The root cause of this portion of the event was determined to be use error.Further action is not deemed necessary at this time.

Manufacturer Narrative

Exemption number e2017016.Siemens healthineers malvern usa (importer) is submitting the report on behalf of siemens shanghai, medical equipment ltd., shanghai (manufacturer).Siemens has completed the investigation of the reported event.The investigation revealed that a "table top moves in" failure occurred when the user was performing top scanning of the patient.This failure was attributed to a firmware bug which affected the communication between ptab and the motor controller, or the communication with the motor controller itself.This was the root cause of the ct system stopping during imaging.The investigation has shown that the customer could resume imaging by restarting the system.This resolution was communicated to the customer.For the system resume, cts.512886 solved the firmware bug in va20.As previously reported, when the system stopped working during the reported event, the user did not follow the system instructions for use for manual table movement and removed the patient from the table without the table being pulled out from the gantry.This resulted in the reported patient injury.The root cause of this portion of the event was determined to be use error.Further action is not deemed necessary at this time.

• Brand Name: SOMATOM GO.NOW
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai, 20131 8; CH 201318
• MDR Report Key: 8041838
• MDR Text Key: 126249299
• Report Number: 3003202425-2018-53887
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K173632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061618
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR