Events

Recall of Device Recall Covidien

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett Inc. (dba Covidien LP).

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
    68802
  • Event Risk Class
    Class 2
  • Event Number
    Z-2235-2014
  • Event Initiated Date
    2014-07-17
  • Event Date Posted
    2014-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128767
  • 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(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    Covidien is conducting a field correction of the vital sync virtual patient monitoring platform and informatics manager due to a mismatch between the alarm priority on the medical devices and the vital sync system.
  • Action
    The firm, Covidien, sent an "URGENT FIELD CORRECTIVE ACTION NOTICE" letter dated 7/16/14 to its customers on 7/17/14 via FedEx. The letter informs users that a representative will be in contact to schedule a software update.The letter also described the product, problem and actions to be taken. The customers were instructed to disregard the audible and visual alarm priority indicators and only use the alarm description text on the patient tile and on the patient detail page for alarm priority information, until the mismatch is corrected. The Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System may still be used until the software update is available. If you have questions about this letter or to report any issues with the Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System, contact our Technical Support Department at (800)635-5267, option 3, then option 1.

Device

Device Recall Covidien
  • Model / Serial
    Model # 10116080 ; Lot # PO643063
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Product Description
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA