DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
This recall has been terminated (originally issued December 11, 2012).
- Recall Initiated
- August 11, 2010
- Posted
- December 11, 2012
- Terminated
- August 2, 2013
- Recall Number
- Z-0513-2013
- Quantity
- 124 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
Distribution
Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
Lot / Code Info
K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001
Root Cause
Device Design
Action Taken
Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue.