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 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Change healthcare investigated the reported issue and determined there was a software defect in change healthcare enterprise viewer (chev).The problem occurs when a scheduled study exists in a pacs patient record and a more recent performed study from the same patient record is opened in chev.Images from the opened (anchor) study are displayed in the viewport but the anchor study details and image thumbnails are not displayed on the patient timeline.The missing timeline information could potentially lead to a study context error.

Event Description

A neurosurgeon initially misinterpreted anchor images displayed in the viewport of the change healthcare enterprise viewer (chev) as a prior study.It was reported this caused the neurosurgeon to almost use the wrong image for surgery.No adverse consequences were reported.

• 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
• Manufacturer (Section G): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: chester mccoy ; 10711 cambie road; richmond, british columbia V6X 3-G5 ; CA V6X 3G5
• MDR Report Key: 11488096
• MDR Text Key: 241806667
• Report Number: 8022257-2021-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 17540262010039
• UDI-Public: (01)17540262010039(10)020100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 02/19/2021
• 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