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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO X WORKPLACE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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SIEMENS HEALTHCARE GMBH SYNGO X WORKPLACE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 10502522
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2017
Event Type  malfunction  
Manufacturer Narrative
Siemens has completed an investigation of the reported event. Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified. The described behavior is caused by a software watchdog in the event too many voi (volumes of interest) punching operations are part of the bookmark. In rare cases, if there is a large volume of data to be processed, a timeout can occur. This may happen if data from different systems are merged (e. G. From angio and ct). The operator may overcome such a situation by either limiting the voi punching or loading the entire 3d volume without using the bookmark function. The manufacturer is not considering further actions resulting from this event as the occurrence is rare and the system is working as specified.
 
Manufacturer Narrative
(b)(4). Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation. (b)(6).
 
Event Description
It was reported to siemens that a malfunction occurred while operating the syngo x workplace system. During a tevar (thoracic endovascular aortic repair), when loading an outside cta (computed tomography angiography) with bookmarks, the 4d viewer closed before overlay for 2d3d fusion could be selected. The result of the error was a delay in procedure. There is no report of impact to the state of health of the patient involved.
 
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Brand NameSYNGO X WORKPLACE
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemensstrasse 1
forchheim, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forcheim, 91301
GM 91301
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, PA 19355
6104486461
MDR Report Key6861652
MDR Text Key252143531
Report Number3004977335-2017-93295
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10502522
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/12/2017
Event Location Hospital
Date Report to Manufacturer08/24/2017
Date Manufacturer Received12/12/2017
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

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