MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SIMVIEW NT SYSTEM, SIMULATION, RADIATION THERAPY

Model Number 5497016

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens completed an investigation of the reported event. The simview nt reached end of support several years ago. The siemens service engineer inspected the device for any damage caused by the event and did not find any damage. If the user is not aware that safety is a priority while operating the simview nt and does not observe the specific warnings contained in the user manual, serious injury can occur by collision. The root cause of the reported event is unknown. It is not known at this time if the event occurred due to user error or device failure.

Event Description

It was reported to siemens that the simview nt detector touched the floor during operation. There was no report of patient mistreatment or injury associated with the reported event. If the user is not aware that safety is a priority while using the simview nt and does not observe the specific warnings contained in the system user manual, serious injury could occur if the gantry or collimator assembly collides with the patient. The reported event occurred in (b)(6).

• Brand Name: SIMVIEW NT
• Type of Device: SYSTEM, SIMULATION, RADIATION THERAPY
• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 9105397
• MDR Text Key: 219786940
• Report Number: 3002466018-2019-96544
• Device Sequence Number: 1
• Product Code: KPQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K946053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 5497016
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/02/2019
• 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