Events

Recall of Flex Cardio Patient Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invivo Corporation.

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
    78465
  • Event Risk Class
    Class 2
  • Event Number
    Z-0082-2018
  • Event Initiated Date
    2017-08-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159623
  • 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
    Intermittent communication between the host system and the flex cardio.
  • Action
    On August 2017 the firm sent letters to their consignees indicating the following: This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. ------------------------------------------- A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur: " Inability of the Flex Cardio to connect to the host system. " Boom Monitor (display) may not display all active waveform and/or vital sign data. " Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor. " After patient admission and case initiation at the host system, the case may not be fully transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will display vital sign data, but the Flex Cardio will not provide audible alarms. " After patient discharge and case termination at the host system, case termination may not be transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will continue to display vital sign data, and the Flex Cardio will continue to provide audible alarms. Our re

Device

Flex Cardio Patient Monitoring System
  • Model / Serial
    Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.
  • Product Description
    Xper Flex Cardio PhysioMonitoring system || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA