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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 10281299
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported to siemens that a malfunction occurred while operating the syngo x- workplace. During an interventional procedure, a 3d dynact spin failed to reconstruct. The procedure was continued and completed on an alternate system. We are unaware of any impact to the state of health of the patient involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameSYNGO X-WORKPLACE
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forccheim, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemensstrasse 1
forccheim, germany 91301
GM 91301
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, PA 19355
6104486461
MDR Report Key9122206
MDR Text Key190829709
Report Number3004977335-2019-98201
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10281299
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
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

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