Model Number 10281299 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/26/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
|
|
Event Description
|
It was reported to siemens that a malfunction occurred while operating the syngo x workplace system.During an interventional procedure, the user reported that while attempting to setup for 3d, the system would not boot correctly.The patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.
|
|
Manufacturer Narrative
|
Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The analyses of the provided log files did not show any hints about system related issues or abnormalities.The service engineer found that there was no image visible on the right side monitor in the control room.After turning off the power to monitor and restarting, the image was visible.The service engineer performed a shutdown of the system and the system rebooted as expected.No other system related issues were identified.This was a single event in the power-on procedure of one of the control room monitors.There was no functional limitation for the in-room control/viewing in the examination room.2d imaging of the artis system was available at all times.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized and this event is considered as a single occurrence event.
|
|
Search Alerts/Recalls
|