|
Model Number 8139789 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/03/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical devices: tabletop 550txt, tt-m multi-purpose (p/n 7349413 s/n (b)(4)); udi: (b)(4); therapy date (b)(6) 2020.Reporting facility phone number: (b)(6).Initial reporter is a reporting facility employee.Siemens completed an investigation of the reported event.The customer provided images that showed the tabletop had became physically unstable, however, a root cause for this issue could not be identified.Siemens customer service engineer installed a new tabletop, which solved the issue.There are no other actions required for this issue.
|
|
Event Description
|
It was reported to siemens that the tabletop deflected and became out of tolerance while a (b)(6) kg.Patient was on it, being prepared for treatment in the pelvic region.The customer observed the issue and used lasers for positioning the patient for treatment.In a worst-case scenario, if the tabletop is physically unstable and goes unnoticed by the user, a treatment dose to an incorrect location could occur.This could lead to a mistreatment with critical/severe injury of several fractions for several patients.No mistreatment or injury of the patient or user have been reported.The reported event occurred in (b)(6).
|
|
Search Alerts/Recalls
|
|
|