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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 10863171
Device Problems Use of Device Problem (1670); Loss of Data (2903)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
The syngo. Plaza is working as designed and intended. With this information, a death or serious injury is highly improbable. (b)(6).
 
Event Description
Siemens became aware of data loss on nas server placed on the syngo. Plaza product. The affected data is dated to the time frame (b)(6) 2017 and (b)(6) 2017. Our factory experts evaluated the reported issue with no risk for the product with potential risk for the user. The user site was a central server deployment with one nas mount point - nas1 - configured as primary in the admin portal. Using an external application ( qnap-qts ), a second nas mount point - nas2 - was setup as backup for nas1. Sequence of events was analyzed and extracted from the log files. Details are below: archive as well as de-archive functions were working as intended until (b)(6) 2017 - 17:31:41. On (b)(6) 2017 the nas1 had some hardware issue. Central server could not reach the nas1. Due to this, both archiving as well as de-archiving functions stopped working until (b)(6) 2017. On (b)(6) 2017 the backup nas2's ip address was changed manually to nas1 ip address, to resolve the archiving and de-archiving issues in the user site. After this change, both functions started working fine. From (b)(6) to (b)(6) archiving was being performed to nas2. During this period the archived files were only present on the nas2. After fixing the hardware issue, the ip address was switched back to re-start archiving to the nas1. The external application (qnap-qts) was activated to restart backup from the nas1 to the nas2. At this point, due to the replica configuration of qnap-qts, the nas2 was brought to content of the nas1 (adding new data but removing data not present earlier on the nas1). Additional files archived in the nas2 during the intermediate servicing time were lost due to this replication. Our experts assessed that data for 4811 patients ranging from (b)(6) 2017 to (b)(6) 2017 was lost. Clinical diagnosis may be potentially affected as old archived data is not available to prior comparison. The syngo. Plaza product is working as designed and intended. The reported data loss was not related to the syngo. Plaza. There are no injuries attributed to this event. 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
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd, mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key8578486
MDR Text Key188866899
Report Number3002808157-2019-77284
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K132532
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 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10863171
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2019
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: 05/03/2019 Patient Sequence Number: 1
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