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

Model Number 14.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 10/10/2018

Event Type  Death  

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 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
• Type of Device: MCKESSON CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE ISRAEL LTD.; 26 harokmim st.,; azrieli center, building a; holon hamerkaz 58858 49; IS 5885849
• Manufacturer (Section G): CHANGE HEALTHCARE ISRAEL LTD; 26 harokmim st.,; azrieli center, building a; holon hamerkaz, 58858 49; IS 5885849
• Manufacturer Contact: paul sumner ; 5995 windward pkwy; 4043383556
• MDR Report Key: 8022584
• MDR Text Key: 125585689
• Report Number: 9616760-2018-00002
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 80010939050027
• UDI-Public: (01)80010939050027(10)140000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• 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: 10/10/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 13 YR