Events

Recall of Device Recall Physiological Monitoring, Patient Monitor

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

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
    57501
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-2011
  • Event Initiated Date
    2010-12-17
  • Event Date Posted
    2011-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96439
  • 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
    Some pas-201 active speaker assemblies in use with the philips intellivue information center (piic) have experienced intermittent audio or loss of audio. speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.
  • Action
    Philips notified all affected customers with an Urgent Medical Device Correction notification letter dated December 17, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to observe their system for any of the described symptoms. If they experience intermittent audio or there is no sound from their PAS-210 speaker while it is not connected to another audible alarm annunciation system, customers were instructed to remove the speaker from use and contact their local Philips service representative. Customers were advised not to rely exclusively on the audible alarm system for patient monitoring, the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. ACTIONS PLANNED BY PHILIPS Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative would contact the customer when the replacement was available. Field Service Engineers will remove and replace defective speakers to correct the problem. The defective speakers will be returned to vendor (Beach Wire) to be discarded. This correction will be done free of charge for customers.

Device

Device Recall Physiological Monitoring, Patient Monitor
  • Model / Serial
    serial #s KVN 0001 through KVN 1071
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA WI, WV, WY, and Canada
  • Product Description
    Physiological Monitoring, Patient Monitor || M31250 Information Center Local Database || Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA