Events

Recall of Draeger Evita V300 with optional PS500

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Draegerwerk AG & Co KGaA.

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
    19463
  • Event Initiated Date
    2015-11-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Reason
    Draeger has become aware of cases in which the battery capacity of the optional ps500 of an iacs workstation critical care (evita infinity v500, evita v300 and babylog vn500 ventilators) was unexpectedly shortened. the batteries were discharged early, even though the device was indicating an adequate battery state of charge. the devices generate a "battery low" alarm, followed by "battery flat". in exceptional cases, the "battery flat" alarm might be displayed too late, or not at all. after complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases., current analysis of the battery data available indicates that an operating time of at least 20 minutes can normally be maintained after the device is disconnected from the power supply, which sufficiently bridges the gap in the event of a mains power failure until the emergency power supply can be activated.
  • Action
    Software to be upgraded

Device

Draeger Evita V300 with optional PS500

Manufacturer

Draegerwerk AG & Co KGaA