MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE ENTERPRISE VIEWER

Model Number 2.1

Device Problems Computer Software Problem (1112); Application Program Problem (2880)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that when viewing studies in change healthcare enterprise viewer (chev), it did not retain the presentation state for the same study saved in pacs.There was no patient harm reported as a result of this issue.The investigation concluded that while this issue was the result of a malfunction, it was not likely to result in a reportable adverse event or serious injury.Further investigations determined this is caused by a software defect that when imaging studies are viewed in chev version 2.1, the studies do not retain the image styles defined by presentation states created and saved in change healthcare radiology solutions (chrs).Image styles include the following attributes of image display: orientation, window/level, and roi (zoom/pan).Change healthcare will be notifying affected customers of this issue and providing a software patch to correct the issue.

Event Description

The customer reported that when viewing studies in chev, they did not retain the presentation state from the same study in pacs.There was no patient harm reported as a result of this issue.

• Brand Name: CHANGE HEALTHCARE ENTERPRISE VIEWER
• Type of Device: ENTERPRISE VIEWER
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• MDR Report Key: 11689299
• MDR Text Key: 250061665
• Report Number: 8022257-2021-00002
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 17540262010039
• UDI-Public: (01)17540262010039(10)020100
• Combination Product (y/n): N
• PMA/PMN Number: K181185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1