MAUDE Adverse Event Report: 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
Medical Device Problem Codes	Computer Software Problem (1112); Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• MDR Report Key: 12724092
• Report Number: 9615916-2021-00002
• Device Sequence Number: 19840672
• 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): 10/29/2021

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• 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
• Usage of Device: N
• Patient Sequence Number: 1