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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH SYNGO IMAGING PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 10014063
Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  malfunction  
Manufacturer Narrative
No consequences from this incident have been reported. With this information, a death or serious injury is highly improbable.
 
Event Description
During migration from the siemens syngo imaging to sectra pacs, it was found that 13 studies had not migrated to sectra pacs. The data loss was of clinical relevance; however, no patient rescans were required. The lost data is old and the clinical relevance of lost data is assessed by siemens experts as very low. Readings and reports for all studies have been successfully generated prior to the incident. Only one image dated 2017 is considered clinically relevant; it was corrupted due to compression after receiving. All other affected studies (9 images from 2008 and one image from 2013) are between 5-10 years old and their clinical relevance was assessed as low. There are no injuries attributed to this event. The reported event occurred in great britain.
 
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Brand NameSYNGO IMAGING
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 Key8532090
MDR Text Key153110201
Report Number3002808157-2018-56475
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082430
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 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10014063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
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: 04/19/2019 Patient Sequence Number: 1
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