MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INC. INTELEPACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number INTELEPACS

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

All versions of intelepacs software with specific misconfiguration to perform html normalization on outbound plain text report could cause reports to be truncated.The issue may be triggered by the presence of the less than character (<) in a plain text report received from an external system.When a report is being forwarded externally to a third system, an incorrectly configured html tag normalization step may erroneously treat unescaped less than (<) signs as tags and remove the text that follows until the next greater than (>) sign from the original report received by intelepacs.The impact of the problem is limited to specific outbound communication channels that are misconfigured.Furthermore, the reports stored in intelepacs are not impacted by this issue, and their entire content can be accessed within intelepacs.

• Brand Name: INTELEPACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): INTELERAD MEDICAL SYSTEMS INC.; 800 boul. de maisonneuve east; 12th floor; montreal, quebec H2L4L 8; CA H2L4L8
• MDR Report Key: 12182909
• MDR Text Key: 264529631
• Report Number: 9615916-2021-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (y/n): N
• PMA/PMN Number: K192176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/16/2021

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: No Information
• Device Model Number: INTELEPACS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/16/2021
• 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: Initial
• Patient Sequence Number: 1