MAUDE Adverse Event Report: CHANGE HEALTHCARE ISRAEL LTD. MCKESSON CARDIOLOGY HEMO

Model Number	14.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sudden Cardiac Death (2510)
Date of Event	10/10/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
As the system appeared to be unresponsive, the reporting facility contacted change healthcare's customer support team for assistance regarding system performance.The reported unresponsiveness did not occur during the patient procedure.When the user was exiting the case, the mckesson cardiology hemo application was synchronizing data from the workstation to the central db resulting in the application appearing unresponsive to the user.
Event or Problem Description
The reporting facility informed change healthcare that the mckesson cardiology hemo application appeared to be unresponsive upon exiting a case in the system following completion of a patient procedure.During the procedure and before exiting the case, the patient expired.

• Brand Name: MCKESSON CARDIOLOGY HEMO
• Common Device Name: MCKESSON CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE ISRAEL LTD.; 26 harokmim st.,; azrieli center, building a; holon hamerkaz 58858 49; IS 5885849
• MDR Report Key: 8022584
• Report Number: 9616760-2018-00002
• Device Sequence Number: 1380654
• Product Code: DQK
• UDI-Device Identifier: 80010939050027
• UDI-Public: (01)80010939050027(10)140000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: 14.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/31/2018
• 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
• Patient Age: 13 YR