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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; Insufficient Information
Event Date 11/15/2017
Event Type  Malfunction  
Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019. The issue is a reportable ae in the usa due to data loss, without contribution of the syngo. Plaza product. The issue is related with a hardware failure and the syngo. Plaza is a software solution only. Customers address: (b)(6).

 
Event Description

Due to hardware issues with the syngo. Plaza's hard drives, a yet unidentified amount of medical images is not accessible anymore. The system was configured as a workstation and not as a pacs. No long term storage archive is configured, thus there is no possibility to restore data from there. Once the restore attempts of the affected hard drives are completed, an updated report will follow containing the detailed information about the data loss.

 
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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 Key8510403
Report Number3002808157-2017-06344
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/22/2017
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 HEALTH PROFESSIONAL
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 Received11/22/2017
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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