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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH SIMVIEW NT SYSTEM, SIMULATION, RADIATION THERAPY Back to Search Results
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).
 
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Brand NameSIMVIEW NT
Type of DeviceSYSTEM, 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 Key9105397
MDR Text Key219786940
Report Number3002466018-2019-96544
Device Sequence Number1
Product Code KPQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K946053
Number of Events Reported1
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 Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5497016
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2019
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

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