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
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 9615916-2021-00003
• Device Sequence Number: 4911864
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown