Events

Field Safety Notices about CARDIOVIT AT-102 Plus

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by SCHILLER.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-01-09
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Patient data mix-up may happen when the setting of “manual send" and “automatic erase after send” is chosen for the data transmission. ecg data interchange only happens with this particular setting. all other settings are not affected. the occurrence is evaluated as rare, considering the limited number of incident reports in relation to the number of ecgs made per year and due to the fact that most customers use auto transmission, and additionally to the fact that data interchange is not likely to happen if the patient is released from the cables before the manual ecg transmission is started.

Device

CARDIOVIT AT-102 Plus

Manufacturer

SCHILLER