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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH SYNGO DYNAMICS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 10090370
Device Problems Use of Device Problem (1670); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2018
Event Type  malfunction  
Manufacturer Narrative
Resubmission of initial report as per fda on 4/3/2019. The clinical relevance of the potentially lost data is that the user no longer has the historical study images available if a comparison with newer images is desired, however the clinical studies and reports created from the read of the image studies will still be available in the sd system unless deleted from the sd system by site it policy or user action. The syngo dynamics product has not caused or contributed to the loss of data.
 
Event Description
Original issue was escalated as a simple request for service support in determining why the syngo dynamics product could not retrieve study images from the site's archive system. Service investigation found that the site's long term archive system (non-siemens product) had failed. The site has turned over the archive disks to a data recovery company. It is not possible for siemens to determine the extent or future availability of the site's historical data. There are no injuries attributed to this event.
 
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Brand NameSYNGO DYNAMICS
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 Key8510402
MDR Text Key141799524
Report Number3002808157-2018-16238
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
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 Number10090370
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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