Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Recall
- Recall Number
- Z-1280-2015
- Event Number
- 70546
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- FEI Number
- 2221819
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 23, 2015
- Posted
- March 16, 2015
- Terminated
- April 20, 2017
- Address
- 800 MacArthur Blvd, Mahwah, NJ, 07430-2001
Description
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Mindray DS USA Inc sent Urgent: Passport V Monitor Field Corrective Action letters dated 1/23/2015 to hospital administrators. The letters informed customers that the IBP module may provide an incorrect IBP measurement. The letter also explained the adverse effects on patients. Customers are asked to either calibrate the IBP following the instructions provided; or, contact a Mindray Service Representative, who can perform the calibration, at 1-800-288-2121. In the case of the second option, it is recommended that the monitor be removed from service until the calibration is performed. If the first option is chosen, customers are to notify a Service Representative upon completion of the action. Customers can direct their questions to Diane Arpino at 201-995-8407.
Nationwide Distribution
519 units