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

Model Number ENHANCED VIEWER, FROM VERSION 4.16.1.EV.1.5.5 TO 4.16.1.EV.1.19.14

Device Problems Computer Software Problem (1112); Missing Test Results (3267)

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

Event Type  malfunction  

Event Description

Description of the problem: the issue may be triggered by the presence of pre-formatted html text in hl7 reports using the

 tag.These reports will be truncated when they are rendered by the enhanced viewer pdf report viewer, which could lead to incomplete report content displayed to the enhanced viewer user.This issue will only happen while using (b)(6) and later versions of these browsers.The impact of the problem is limited to the enhanced viewer module when viewing reports.Furthermore, the reports stored in intelepacs are not impacted by this issue, and their entire content can be accessed within intelebrowser, inteleconnect or inteleviewer.Reports sent externally through hl7 are not impacted.When the specific circumstances described above occur, there is a possibility that incomplete information is presented to the enhanced viewer user.The absence of the information in the report could affect the decisions they make regarding patient care.No patient harm has been reported at this time.			
					
				
				

• 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: 12724092
• MDR Text Key: 282111030
• Report Number: 9615916-2021-00002
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENHANCED VIEWER, FROM VERSION 4.16.1.EV.1.5.5 TO 4.16.1.EV.1.19.14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1