device · product 1 of 1
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.
- Recall number
- Z-0389-2014
- Initiated
- October 07, 2013
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 1839 units
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Environmental control
Inspect official wording and provenance
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.
Code information
V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01
Distribution pattern
Worldwide Distribution - USA Nationwide