MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE RADIOLOGY SOLUTIONS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 14.0

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Change healthcare has identified a software defect which may result in one or more images/dicom objects missing from a study after it is imported into the pacs.This is caused by a discrepancy between the image index and the files stored within the image folders.As a result of this discrepancy, a user may experience one of the following scenarios: 1.The study cannot be opened and an error message is displayed, or 2.The study can be opened and an error is displayed on the viewport of the missing image(s), or 3.The study can be opened and no warning message is presented to the user that there are missing images.The impacted image files are retained in the image folder but are not visible to the user.When the study is archived, these impacted image files may be deleted from the pacs permanently.Change healthcare will work with affected customers to apply a software update to prevent the recurrence of the problem.

Event Description

Following an upgrade to chrs 14.0 a customer site, the customer reported issues on (b)(6) 2020 where some newly imported ultrasound images weren't in order and some of them were cut off and black.There was no patient harm reported as a result of this issue.

• Brand Name: CHANGE HEALTHCARE RADIOLOGY SOLUTIONS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, V6X 3 G5; CA V6X 3G5
• Manufacturer (Section G): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie rd; richmond, V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: chester mccoy ; 5995 windward parkway; alpharetta, GA 30005 ; 5743025855
• MDR Report Key: 10495255
• MDR Text Key: 213252152
• Report Number: 8022257-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 17540262030020
• UDI-Public: (01)17540262030020(10)140000
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 14.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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