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 03/08/2018

Event Type  Death  

Manufacturer Narrative

Reviews of the system logs concluded that the alarms were disabled by the user.Disabling of the alarms is an optional user feature of the mckesson cardiology hemo application.The device operated as intended and designed with no evidence of a malfunction.

Event Description

The reporting facility contacted change healthcare to assist in an investigation into mckesson cardiology hemo - physiological alarms deactivation involving a patient death.

• Brand Name: MCKESSON CARDIOLOGY HEMO
• Type of Device: MCKESSON CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE ISRAEL LTD.; 26 harokmim st.; holon, 58858 49; IS 5885849
• Manufacturer (Section G): CHANGE HEALTHCARE ISRAEL LTD; 26 harokmim st; holon, 58858 49; IS 5885849
• Manufacturer Contact: paul sumner ; 5995 windward pkwy; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 7488292
• MDR Text Key: 107434521
• Report Number: 9616760-2018-00001
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2018
• 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