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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 Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
Resubmission of initial report as per fda on 4/3/2019. Activities are ongoing to evaluate the exact amount of affected studies and the possibility of restoring them. No issue from syngo. Plaza software since syngo. Plaza did not contribute to the data loss at the site. No consequences have been reported, neither from this customer nor from the installed base. (b)(6).
 
Event Description
Per the potential complaint report, there was no injury associated with this issue. No mix-up occurred, hence, no patient rescan was required. Customer reported that certain studies cannot be found in syngo. Plaza patient browser. The system was migrated and upgraded from an old syngo. Plaza version to a new server and new sw version vb20a in (b)(6) 2017. During the analysis of this issue it has been identified that an incorrect license file is present on the system. Thus studies were not archived to syngo. Plaza's long term archive. The affected studies were present in the online storage for reporting of current examinations. After a certain fill level was reached in the online storage, the studies were removed by autodeletion function. The affected studies range from 01/2017 to 07/2017 and are not available for prior comparison. 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 Key8560715
MDR Text Key162362491
Report Number3002808157-2018-12788
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K093612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
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 Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/29/2019 Patient Sequence Number: 1
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