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

Model Number 14.1.1

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2019

Event Type  malfunction  

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 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
• Type of Device: CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT
• Manufacturer (Section D): MCKESSON ISRAEL LTD.; 26 harokmim st. azrieli center; building a; holon, 58858 49; IS 5885849
• Manufacturer (Section G): MCKESSON ISRAEL LTD.; 26 harokmim st.; azrieli center building a; holon, 58858 49; IS 5885849
• Manufacturer Contact: chester mccoy ; 5995 windward parkway; alpharetta, ga ; 3382088
• MDR Report Key: 9731293
• MDR Text Key: 206132800
• Report Number: 9616760-2020-00001
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 17540262110029
• UDI-Public: (01)17540262110029(10)140101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 14.1.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2019
• 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