MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM SENSATION OPEN; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8872017

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Reporting facility telephone number is: (b)(6).Siemens has initiated a technical investigation of the reported event.The root cause has not been identified.Siemens recommended to the customer that they perform a monthly constancy check to ensure the correct geometry is obtained.Additionally, siemens recommended a position verification at the linac (linear accelerator for radiation therapy) to ensure correct patient positioning before the first treatment.A supplemental report will be submitted upon the completion of the investigation.

Event Description

It was reported to siemens that during use of the somatom sensation system, the tabletop was not horizontally leveled.When the phs tabletop was moved horizontally to its outmost position, the tabletop level was correct.But when phs tabletop was moved into the gantry, the tabletop head (which is used to install the head-holder) dropped.The maximum drop distance was about 7.5mm.Meanwhile the table had been adjusted.The customer did initially not call the siemens service organization but reported this issue to the chinese authority.The was no reported injury to the patient.There was also no need for patient rescan.Since the ct system is used for cancer treatment planning, it was alleged, that during a later radiation treatment this offset in the table position could result in an incorrect treatment (dose to wrong location).The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens had completed the technical investigation of the reported issue.It has been confirmed by the subject expert that the missing rubber strip can have an influence on the table geometry.The rubber strip is fixed (glued) to the tabletop carriage before the tabletop is mounted.After mounting the tabletop, the rubber strip is firmly and permanently inserted into the screw connection (between tabletop and table top carriage).Therefore, the rubber strip cannot get lost accidently, it must be removed consciously.Siemens analyzed the complete service history of the system.As of 2020/06/26, no service activity is noted, with which the tabletop would have had to be replaced or dismantled.Therefore, it is not plausible, that the rubber strip was missing.Siemens also checked the installation protocol and found that the installation was performed according installation instruction ct02-023.814.66.27.02.08.14.This confirms that the system was handed over in specification the customer on 2011/01/25.Siemens was informed that the customer did not have a service contract.Furthermore, siemens requested the history of the qa (quality assurance).The last external laser check had been performed on 2012/02/16.According user manual c2-023.620.35.03.02 the constancy check must be done monthly.In conclusion, siemens cannot determine when the table geometry has changed.According to our knowledge, no siemens employee manipulated the table.If the monthly qa would have been performed, the issue would have been recognized earlier.A calibration of the external lasers can compensate minor deviations of the table deviations (users' responsibility).Siemens cannot identify a general product or design issue.After repair of phs and alignment with external laser, the system works fine.No recall activity is deemed necessary.This is considered as an isolated issue.

• Brand Name: SOMATOM SENSATION OPEN
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10487323
• MDR Text Key: 205878247
• Report Number: 3004977335-2020-35626
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K142955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8872017
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1