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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 12/03/2017
Event Type  malfunction  
Manufacturer Narrative
Siemens factory experts evaluated the reported issue within the acceptable risk threshold for the product, however, relevant risk for the site due to data loss of clinical relevant data was identified. No consequences have been reported from this customer.
 
Event Description
Our factory experts evaluated the reported issue within the acceptable risk threshold for the product, however, relevant risk for the site was identified. The syngo. Plaza has been configured to use a primary (nas1) and backup (nas2) network attached storage (nas) mount point for archiving purposes. Due to an unrecoverable hardware failure on the nas1 a restoration of all data was performed from the nas2. However, the nas2 did not contain all archived data as on nas1. 8523 series dated within the timeframe 2011-2016 were not in the archive and no longer available. This is considered a data loss of clinical relevant data. The root cause analysis was able to limit down the issue to a manual intervention on the nas2's filesystem, which is not no longer traceable. The syngo. Plaza did not contribute to the missing data in the nas2 archive. There are no injuries attributed to this event. The reported event occured in the (b)(6).
 
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Brand NameSYNGO.PLAZA
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkestrasse 16
erlangen, 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkestrasse 16
erlangen, 91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd, mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key8510406
MDR Text Key152528489
Report Number3002808157-2018-15374
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
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
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 Received01/31/2018
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: 04/12/2019 Patient Sequence Number: 1
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