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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO.PLAZA PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

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SIEMENS HEALTHCARE GMBH SYNGO.PLAZA PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 10592457
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2019
Event Type  malfunction  
Manufacturer Narrative
When the user loaded the studies, an error should have been displayed to the user indicating an issue. It was confirmed that the syngo. Plaza had sent the error status to modality for the corrupted images. In this case syngo. Plaza application worked as specified. No consequences have been reported, neither from this customer nor from the installed base. Internal id # (b)(4).
 
Event Description
Siemens became aware of files being corrupted on the syngo. Plaza system with software version (b)(4). From the available logs, it was observed that all syngo. Plaza services shut down abnormally at the time of file creation. This resulted in corrupted files for studies, which were received during the shutdown. In total 125 files from 10 studies were corrupted - 100 files from 2019 and 25 files from 2017. There was no injury associated with the issue. The reported event occurred in (b)(6).
 
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Brand NameSYNGO.PLAZA
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key9465664
MDR Text Key191434877
Report Number3002808157-2019-89096
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K132532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10592457
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
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

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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