MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INC. INTELEPACS

Model Number ENHANCED VIEWER 1.17.4 TO 1.19.19 AND INTELEVIEWER 4-3-1 R1 TO 5-4-1

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

When using advanced visualisation to reconstruct mr, ct and pet images that contain non-square pixels, the reconstructed image is incorrect.Non-square pixels occur when the row and column pixel spacing values are different.Measurements made on this image are also consequently erroneous.This issue does not affect measurements made on regular 2d views.When using advanced visualisation in the enhanced viewer to reconstruct mr and ct images that have non-orthogonal volume axes (e.G.Gantry tilt), linear measurements will be incorrect due to the use of an incorrect formula.This only occurs for measurements made on a re-oriented view (e.G.Mpr).Inteleviewer can be affected when using the ev advanced visualisation view embedded inside inteleviewer (inteleviewer versions 5.4.1.R1 and later).Hazard involved: when the specific circumstances described above occur, there is a possibility of displaying distorted images along with erroneous measurements.The distortion and measurement difference could affect decisions regarding patient care.For issue 1, the maximum measurement error is proportional to the ratio of row and column pixel spacings.No patient harm has been reported at this time.This is merely a precautionary report.

• Brand Name: INTELEPACS
• Type of Device: INTELEPACS
• Manufacturer (Section D): INTELERAD MEDICAL SYSTEMS INC.; 800 de maisonneuve e. blvd.; 12th floor; montreal, quebec H2L 4 L8; CA H2L 4L8
• Manufacturer (Section G): INTELERAD MEDICAL SYSTEMS INC.; 800 de maisonneuve e. blvd.; 12th floor; montreal, quebec H2L 4 L8; CA H2L 4L8
• Manufacturer Contact: christopher pearce ; 800 de maisonneuve e. blvd.; 12th floor; montreal, quebec H2L 4-L8 ; CA H2L 4L8
• MDR Report Key: 13017666
• MDR Text Key: 285363828
• Report Number: 9615916-2021-00003
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENHANCED VIEWER 1.17.4 TO 1.19.19 AND INTELEVIEWER 4-3-1 R1 TO 5-4-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1