Events

Recall of Draeger Evita 300 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
    19774
  • Event Initiated Date
    2016-02-19
  • 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
    Manufacturer has become aware of cases in which the battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 was rapidly and unexpectedly reduced despite using the most recent power supply firmware (fw1 .50) which was released in november 2015. the batteries prematurely discharged, even though an adequate battery charge status was displayed on the device. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. given these new findings, the decision has been made to cancel the distribution of the updated power supply firmware (fw1.50) and to roll back devices on which this firmware version is already installed to fw1.49.
  • Action
    Product to be exchanged

Device

Draeger Evita 300 with optional PS500

Manufacturer

Draegerwerk AG & Co KGaA