Events

Field Safety Notices about PRIMEDIC™ AkuPak LITE

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 Metrax GmbH.

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
    2016-06-07
  • 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
    If the primedic™ defimonitor xd is stored for long periods with the primedic™ akupak lite inserted and with direct connection to the mains power via the integrated mains unit, the defibrillator is only supplied from this source in the course of the daily self-test, i.E. no power is taken from the battery inserted in the unit. this means that the battery management system (bms) integrated in the primedic™ akupak lite will not have its residual capacity checked by a new evaluation throughout the entire period. for this reason, internal power consumption and chemical self-discharge of the cells can result in a reduction in the capacity, without starting a charging process for the primedic™ akupak lite. a new evaluation of the residual capacity will only take place when the primedic™ defimonitor xd is disconnected from the mains and is switched on. .

Device

PRIMEDIC™ AkuPak LITE

Manufacturer

Metrax GmbH