MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE CARDIOLOGY HEMO; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	15.1
Medical Device Problem Codes	Human-Device Interface Problem (2949); Inadequate User Interface (2958)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After conducting a thorough investigation into the customer's use error, change healthcare has determined that all software functionality related to changing the uom was working as expected.However, change healthcare is analyzing whether the user interface design was effective enough to timely alert the user.
Event or Problem Description
Change healthcare cardiology hemodynamics provides hemodynamic calculations and formulas.The settings, such as unit of measurement (uom), for these formulas and calculations are configured in the change healthcare management console (chmc) and are designated by the site according to facility standards.In this event, the uom for the hemoglobin value, used as part of the hemodynamics formulas, was configured in the chmc as mmol/l (millimoles/liter).However, the clinical staff continued to manually enter the hemoglobin value as g/dl (grams/deciliter) without being aware of the changed configuration for the uom.No adverse heath consequences resulting from this issue were reported to change healthcare.

• Brand Name: CHANGE HEALTHCARE CARDIOLOGY HEMO
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer (Section G): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: jay sloman ; 10711 cambie road; richmond, british columbia V6X 3-G5 ; CA V6X 3G5
• MDR Report Key: 19844346
• Report Number: 8022257-2024-00002
• Device Sequence Number: 20495025
• Product Code: MWI
• UDI-Device Identifier: 17540262100129
• UDI-Public: (01)17540262100129(10)150100
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Patient Sex: Unknown