Events

Recall of Device Recall Mindray DS USA, Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. dba Mindray North America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70546
  • Event Risk Class
    Class 2
  • Event Number
    Z-1280-2015
  • Event Initiated Date
    2015-01-23
  • Event Date Posted
    2015-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134011
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    An issue has been identified with passport v monitors invasive blood pressure function (ibp) which may provide an incorrect ibp measurement.
  • Action
    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.

Device

Device Recall Mindray DS USA, Inc.
  • Model / Serial
    6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America