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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNAPTIVE MEDICAL INC. CLEARCANVAS RIS/PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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SYNAPTIVE MEDICAL INC. CLEARCANVAS RIS/PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number PERSONAL EDITION WORKSTATION 13.1
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
The customer demonstrated that the anatomy was not visible through remote access. The probe tool was used to check the brightness values. Brightest areas had values around 190-200. Dicom headers displayed a window center (0028,1050) value of 2,700. Center value should be roughly between the brightest and darkest pixel values. It was determined that the modality is writing the center value differing from the brightest spot. It was determined at this time that the product functioned as intended and this issue was due to incorrect dicom data. A workaround was provided to the customer if the issue is encountered again. On 04-feb-2020, a software defect was discovered while investigating an issue regarding a research device. This led to a retrospective analysis of feedback tickets. The research device uses the same (b)(4) codec as the device described in this report. While the likelihood of potential serious health consequences is remote, the use of the defective software associated could result in misdiagnosis, potentially causing significant indirect harm necessitating medical intervention that is serious but temporary. This defect is only encountered in select scenarios, where a modality produces images that are compressed using (b)(4), and the image pixel data is less than 16-bit, and the "bitness" of the compressed data stream does not match that of the image pixel data. The outcome of the above is a loss of precision in the decompressed pixel data, which causes the symptoms that were reported by the customer. The root cause is that a software defect found in the device that is encountered when it is used with non-dicom compliant (b)(4) compressed images. The software improperly uses the dicom bit depth (i. E. The bits stored tag) to decompress the compressed pixel data stream for display, instead of the bit depth that is encoded in the compressed pixel data stream itself. In non-dicom compliant images where the dicom and compressed pixel data stream bit depths do not match, the software outputs an image with some loss of precision in the decompressed pixel data. In these scenarios, the modality producing the image is itself also not compliant to dicom (b)(4). Mdr reports: 3012075008-2020-00002, 3012075008-2020-00003 and 3012075008-2020-00004 have the same root cause. A capa has been opened and recall initiated to address the issue in affected devices.
 
Event Description
On (b)(6) 2017 a customer submitted a complaint indicating that mammogram images appeared dark when loaded in clearcanvas ris pacs. No adverse effects to the patient have been reported as occurring.
 
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Brand NameCLEARCANVAS RIS/PACS
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
SYNAPTIVE MEDICAL INC.
555 richmond street w.
suite 800
toronto, on M5V 3 B1
CA M5V 3B1
Manufacturer Contact
maham ansari
555 richmond street w
suite 800
toronto, on M5V3B-1
CA   M5V3B1
MDR Report Key9777538
MDR Text Key222012841
Report Number3012075008-2020-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPERSONAL EDITION WORKSTATION 13.1
Device Catalogue NumberSYN-0524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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