Events

Recall Or Safety Alert for Devices of artificial ventilation of the lungs with accessories: Devices of artificial ventilation of the lungs Evita Infinity V500, Babylog VN500

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Drager Medical GmbH, GERMANY.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety alert
  • Event Number
    ИМ-7.97782
  • Date
    2014-04-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. 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 Belarus.
  • Extra notes in the data
  • Reason
    As part of the supervisory activities of drager medical gmbh, it became known that when using an additional ps500 power supply unit when connected to evita infinity v500 and babylog vn500 ventilators, the battery capacity holds the charge not as long as expected, although the battery indicator shows a fairly charged battery. in this case, the indicators (alarms) "low battery" (battery low) and "power source discharged" (battery depleted) do not always work when the battery level is below 10%. to ensure the normal operation of the devices, it is necessary to contact the representative of drager and organize the exchange of the battery as a temporary solution. before exchanging the battery, drager recommends: 1. use an additional power supply to transport the patient only if absolutely necessary. 2. do not rely on the battery status indicator. 3. always monitor the patient and the ventilator during transport. ensure that there is a breathing bag for manual ventilation, as indicated in the manual for ventilators. 4. if the power supply is discharged during transportation, it is necessary to provide manual ventilation of the lungs and immediately connect the ventilator to the wall-mounted power supply to resume ventilation of the lungs.

Device

Devices of artificial ventilation of the lungs with accessories: Devices of artificial ventilatio...

Manufacturer

Drager Medical GmbH, GERMANY