Events

Field Safety Notices about PS500 external battery

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Drager.

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
  • Event Date Posted
    2017-10-03
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/03/10/obavestenje-o-medicinskom-sredstvu-evita-infinity-v500-ventilator/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    As part of our continued market and product monitoring we had become aware of cases in which the battery capacity of the optional ps500 power supply unit for the infinity critical care workstation (evita infinity v500), infinity neonatal care workstation (babylog vn500) and evita v3000 was unexpectedly reduced. drager then consequently issued the above referenced safety notice in january 2016. drager now announces that we have developed an improvement and are making it available to you free of charge so that you can fully utilize your device.

Device

PS500 external battery

Manufacturer

Drager