Company:Mindray DS USA, Inc. dba Mindray North America.
Date of Enforcement Report: 7/23/2014
Class lI:
PRODUCT
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Recall Number Z-2059-2014
REASON
Several issues with the V-Series Monitoring System 12-lead ECG interpretation feature. These issues impact the 12-lead ECG feature only; standard 12-lead ECG monitoring is not affected. (1) The 12-lead Standard and Extended Measurement Report will include false measurements when the P wave or QRS axis cannot be accurately determined by the algorithm. (2) The Median Complex and Extended Measurement Report will display the representative beat as 25% larger than actual signal input. (3) When a patient date of birth is imported into the V Series from an external source, such as Mindray’s Gateway, e-Gateway, Panorama Central Station or Panorama Workstation, the age will not pass into the 12-lead ECG interpretation algorithm. The algorithm analysis will use the default adult criteria of “50 year adult” in which case the interpretive statements may be incorrect, depending on the actual age of the patient. Note: when the patients date of birth is manually entered into the V-Series the correct age is accepted and the appropriate interpretation algorithm is applied.
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ on 5/19/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
113 units (57 United States; 56 International)
DISTRIBUTION
Nationwide and Internationally
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