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

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.

• Brand Name: CLEARCANVAS RIS/PACS
• Type of Device: SYSTEM, 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 Key: 9777538
• MDR Text Key: 222012841
• Report Number: 3012075008-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110332
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERSONAL EDITION WORKSTATION 13.1
• Device Catalogue Number: SYN-0524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1