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

Model Number	14.0
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, V6X 3 G5; CA V6X 3G5
• MDR Report Key: 10495255
• Report Number: 8022257-2020-00001
• Device Sequence Number: 2939066
• Product Code: LLZ
• UDI-Device Identifier: 17540262030020
• UDI-Public: (01)17540262030020(10)140000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 14.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1