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U.S. Department of Health and Human Services

Class 2 Device Recall V Series Monitor, Mindray DS USA, Inc

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  Class 2 Device Recall V Series Monitor, Mindray DS USA, Inc see related information
Date Initiated by Firm October 07, 2013
Date Posted November 25, 2013
Recall Status1 Terminated 3 on April 27, 2015
Recall Number Z-0389-2014
Recall Event ID 66755
510(K)Number K102004  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)

Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Code Information V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Mr. Wayne Quinn
800-2882121
Manufacturer Reason
for Recall		 Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.
FDA Determined
Cause 2		 Environmental control
Action Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product.
Quantity in Commerce 1839 units
Distribution Worldwide Distribution - USA Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = MINDRAY DS USA, INC.
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