Events

Recall of Device Recall Remote Patient Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vidco, 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
    72794
  • Event Risk Class
    Class 2
  • Event Number
    Z-0582-2016
  • Event Initiated Date
    2015-11-08
  • Event Date Posted
    2016-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142223
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Reason
    Testing at customer site showed unit remote patient monitoring system mdp2040-0100 in a continuous trap condition, not allowing system to reset and reboot. two customers recently complained of the system freezing and it could only be restarted if the user re-applied power.
  • Action
    The firm began notifying consignees on Nov. 8, 2015 and followed up with the Advisory Notice letter, dated November 10, 2015. VIDCO identified the root cause and has corrected software that is currently going through validation. This software will be made available for updating the MDP2040-0100 as soon as it is released. The units may be updated on-site with the software program that will become available on the File Transfer Protocol (FTP) site. If you are unable to perform the procedure yourself, VIDCO will assist you in this effort. The current software version can still be used for monitoring as long as the user confirms the displays are still dynamically writing waves to the screen (i.e. waves will be changing in real-time). Consignees with questions can call (503) 641-1804 or 800-638-4326, or send email to sales@vidcoinc.com

Device

Device Recall Remote Patient Monitoring System
  • Model / Serial
    Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
  • Product Description
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. || The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.
  • Manufacturer
    Vidco, Inc.

Manufacturer

Vidco, Inc.
  • Manufacturer Address
    Vidco, Inc., 6175 Sw 112th Ave, Beaverton OR 97008-4838
  • Manufacturer Parent Company (2017)
    Vidco Inc
  • Source
    USFDA