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

Model Number	14.1.1
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Change healthcare's investigation determined that the root cause of the issue is design deficiency.The ecg waveforms can be displayed by simultaneous or sequential ecg format options, depending on user configuration.By default, the simultaneous ecg format is presented on a scale of 25 mm/sec whereas the sequential view scale is dynamically changed depending on the monitor's resolution, and therefore may be displayed using other scales rather than 25mm/sec.Users who are estimating heart rate solely by counting grid squares, may assume that the sequential ecg format is presented on a scale of 25 mm/sec, and thereby may inaccurately estimate the heart rate value.Change healthcare will provide a software update to correct the issue in all affected versions of the software.In addition, change healthcare will provide instructions (via field safety notice) to all affected customers to inform them of this issue and mitigations.
Event or Problem Description
The ecg waveforms grid scale, in the specific "sequential' configuration is dynamically changed based on the screen resolution in use.Therefore, the ecg waveforms may be displayed using other scales rather than 25mm/sec.The on-screen scale bar correctly indicates the actual scale used for the display, and the heart rate value as sent from the cart/ calculated by the system is clearly displayed on the screen and is not affected by the issue.In addition, the sequential layout used in the ecg pdf report is displayed in the 25 mm/sec scale.The issue was reported during an ecg management implementation by the customer, prior to using the device in clinical use.No patient harm was reported as a result of this issue.

• Brand Name: CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT
• Common Device Name: CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT
• Manufacturer (Section D): MCKESSON ISRAEL LTD.; 26 harokmim st. azrieli center; building a; holon, 58858 49; IS 5885849
• MDR Report Key: 9731293
• Report Number: 9616760-2020-00001
• Device Sequence Number: 13543426
• Product Code: DQK
• UDI-Device Identifier: 17540262110029
• UDI-Public: (01)17540262110029(10)140101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: No Information
• Device Model Number: 14.1.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1