Device product

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Z-1682-2020

February 10, 2020

Class II

Product summary

Firm: CHANGE HEALTHCARE CANADA COMPANY
Event: Event 85068
Status: Ongoing
Classification: Class II
Quantity: 51 units
Official record key: device-enforcement:Z-1682-2020

Official wording

Reason: Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

Code information: McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2

Distribution pattern: Distribution US nationwide, Canada and the United Kingdom

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format