Events

Field Safety Notices about klinoPORT

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 TRUMPF Medizin Systeme GmbH + Co. KG.

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 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
    Trumpf medical has been notified of an event in which the motor height-adjustable arm of the klinoport ceiling supply unit unexpectedly dropped to its lowest possible position. analysis the cause was shown by broken motor drive welds. in the event that the motor height adjustable arm falls suddenly or unexpectedly to its lowest position due to this defect, there is a risk of serious injury to patients or users.

Device

klinoPORT

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG