MAUDE Adverse Event Report: INTELEPACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number	INTELEPACS
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• MDR Report Key: 12182909
• Report Number: 9615916-2021-00001
• Device Sequence Number: 19850241
• Product Code: LLZ
• UDI-Device Identifier: B228INTELEPACS0
• UDI-Public: B228INTELEPACS0
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: INTELEPACS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1