MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE CARDIOLOGY HEMO

Model Number 14.2

Device Problems Application Network Problem (2879); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  Death  

Manufacturer Narrative

The reporting facility stated that the device did not cause or contribute to the death of the patient.Preliminary investigation revealed that the reported malfunction was associated with the network cabling or associated components.The reporting facility confirmed that the connection between the rt monitor and the infosystem was restored successfully after replacement of the network hardware component.Further investigation is still in process to determine the root cause of the event.Change healthcare will provide a follow up report to the agency once additional information is available.

Event Description

It was reported that during an emergency stemi procedure in the catherization lab involving a patient in critical state, the control panel on the infosystem's application was greyed out and as a result, the users were not able to control the rt monitor or take hemodynamic samples using the infosystem.The user did not use the rt monitor keypad which allows control over the rt monitor display when the control panel of the infosystem is greyed out, as indicated in the change healthcare hemo user guide.The patient was then moved to a different lab where the procedure was completed.Subsequent to the procedure the patient expired.During the procedure the patient was also connected to anaesthesia equipment which allowed auxiliary monitoring of the patient's vitals signs.

Event Description

It was reported that during an emergency stemi procedure in the catherization lab involving a patient in critical state, the control panel on the infosystem's application was greyed out and as a result, the users were not able to control the rt monitor or take hemodynamic samples using the infosystem.The user did not use the rt monitor keypad which allows control over the rt monitor display when the control panel of the infosystem is greyed out, as indicated in the change healthcare hemo user guide.The patient was then moved to a different lab where the procedure was completed.Subsequent to the procedure the patient expired.During the procedure the patient was also connected to anaesthesia equipment which allowed auxiliary monitoring of the patient's vitals signs.

Manufacturer Narrative

Final investigation revealed that the reported malfunction, related to a problematic nic connection, was due to a faulty cable, previously reported as an incomplete os boot of the rt monitor.Support's investigation revealed that the boot was not successful and resulted in communication issues between the infosystem and rt monitor.Once support assisted with performing a clean reboot of the rt monitor and reconfiguration of the nic card, the connection was restored successfully and there were no further issues encountered.

• Brand Name: CHANGE HEALTHCARE CARDIOLOGY HEMO
• Type of Device: CHANGE HEALTHCARE CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; v6x 3g5; richmond, bc ; CA
• Manufacturer (Section G): CHANGE HEALTHCARE CO; 10711 cambie road; richmond, bc V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: chester mccoy ; 5995 windward parkway; alpharetta, GA 30005 ; 4043382088
• MDR Report Key: 12018365
• MDR Text Key: 256769727
• Report Number: 9616760-2021-00001
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 17540262100037
• UDI-Public: (01)17540262100037(10)140200
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic