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
    26992
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-11
  • 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
    If a low spo2 (yellow) medium grade alarm is generated and subsequently paused by the user by using the alarm pause function and the spo2 further decreases to reach the set alarm limit for the high grade life threatening spo2 alarm then the iacs may not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit or on the central station. only the m540 showed the red signal. the correct spo2 value is indicated on all devices. this behavior happens only in neonatal mode. pediatric or adult mode does not have this latching alarm feature for spo2 desaturation therefore the problem cannot occur with these modes.

Device

IACS MONITORING SOLUTION WITH C700
  • Model / Serial
    Model Catalog: MS25520 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: MS25510 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    IACS MONITORING SOLUTION WITH C700
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.