MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV SYSTEM; ACCELERATOR, LINEAR, MEDICAL

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).

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; ms 65-1a; malvern, pa ; 4486471
• MDR Report Key: 10230297
• MDR Text Key: 232759929
• Report Number: 3002466018-2020-34713
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 100