MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY MCKESSON RADIOLOGY; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number	12.3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Change healthcare's customer support team successfully located the imaging study for the patient in mckesson radiology pacs.Upon further investigation, change healthcare's customer support team determined that the study had been sent to mckesson radiology from an upstream system without an assigned medical record number (mrn).In this situation, mckesson radiology pacs is designed to assign a temporary mrn using a designated prefix upon import to clearly identify imaging studies needing further demographic review.Users are expected to identify and update the temporary mrn field during the review workflow following import of an imaging study.Mckesson radiology pacs provides additional features to enable users to search for and locate imaging studies in the system using different methods; for example, by using the accession number search or using the "recently performed" study list filter.Mckesson radiology pacs performed as designed.
Event or Problem Description
The reporting facility contacted change healthcare's customer support team to determine whether an imaging study performed for an emergency patient had been imported into mckesson radiology pacs from the modality, as the reporting facility had been unable to locate the study in the system.The reporting facility indicated the patient had subsequently expired.

• Brand Name: MCKESSON RADIOLOGY
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• MDR Report Key: 8220473
• Report Number: 8022257-2018-00002
• Device Sequence Number: 2266990
• Product Code: LLZ
• UDI-Device Identifier: 17540262020014
• UDI-Public: (01)17540262020014(10)120300
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 12.3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death