Events

Recall of IACS MONITORING SOLUTION WITH C700

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA 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
    32616
  • Event Risk Class
    I
  • Event Initiated Date
    2011-10-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The weight-based drug dosage calculation may deliver incorrect recommendation values if the patient's body weight is not entered via the admin-/demographics screen but entered via the drug dosage application screen. one hospital in germany also reported a misalignment of ecg and art waveforms delivered from this product.

Device

IACS MONITORING SOLUTION WITH C700
  • Model / Serial
    Model Catalog: MS25520 (Lot serial: 5610433372); Model Catalog: MS25520 (Lot serial: 5610224874); Model Catalog: MS25520 (Lot serial: 5610434870); Model Catalog: MS25520 (Lot serial: 5610433470)
  • Product Description
    INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.