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

Model Number	14.2
Medical Device Problem Codes	Application Network Problem (2879); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Death
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9616760-2021-00001
• Device Sequence Number: 17210866
• Product Code: DQK
• UDI-Device Identifier: 17540262100037
• UDI-Public: (01)17540262100037(10)140200
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 14.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic