MAUDE Adverse Event Report: CHANGE HEALTHCARE TECHNOLOGIES LLC MCKESSON ARCHIVAL SYSTEM; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

Patient had a procedure done in catheter laboratory.Unable to find the films on the mckesson archival system.There was an error message on the computer during this time.The films could not be transferred over until the error message was cleared.Once the error message was corrected the films were available.All films for this patient are present.There is a process in place, so that this will not happen.Films are to be checked daily to be sure they have transferred over to mckesson.Any missing films due to error messages should be addressed in real time.Cath lab assistant nurse manager huddled with team members regarding this process and to be sure that they are following it daily and with all cases.

• Brand Name: MCKESSON ARCHIVAL SYSTEM
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): CHANGE HEALTHCARE TECHNOLOGIES LLC; 5995 windward parkway; alpharetta GA 30005
• MDR Report Key: 7582443
• MDR Text Key: 110486081
• Report Number: 7582443
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR