Events

Field Safety Notices about HARTMANN VivanoTec® and ATMOS® S 042 NPWT negative pressure therapy units

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 ATMOS MedizinTechnik 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
    1.1 immediate activation of the keypad lock after closing the warning message window in the case of an alert (eg >> filler collector <<, >> stuffed pipe ", etc.), the key lock has been disabled so that the user can confirm the alert message. the lockout was then left inactive for one minute so that the user could change the device settings. while observing the market, it turned out that some users or patients in this brief eas were unknowingly changing their device settings. based on this finding, the delayed activation of the keylock was canceled, so that the keylock is now activated again immediately after confirmation of the warning message. 1.2 optically highlighted start / stop key the control area for starting and stopping therapy - the "start / stop" button on the touch screen - has been highlighted in blue in the software versions so far; after switching on the device or after stopping therapy, alternating switching between light blue and dark blue indicated that therapy should be started again. while observing the market, it was found that users of these opti- mers (alternating between light blue and dark blue) were not always detected and therefore therapy was delayed. therefore, the control area for starting and stopping therapy ("start / stop key") is now green. the switch between light green and dark green is now clearly distinguished from the 0d of the other parts of the control surface, which have always turned blue, so that the system catches the user's attention. the colors in the operating instructions that show this control surface have been modified accordingly. 1.3 changed intervals for intermittent operation so far in the intermittent mode of operation it has been possible to set the wash interval from 1 minute to 10 minutes. at very short eas intervals (eg 1 minute of the highest cial negative pressure and 1 minute of the lowest target negative pressure), in the case of detected leakage, the warning is withdrawn because the mode has changed with a short eas. while observing the market, it appeared that some users had been misled by the display of a brief eas alert. therefore, the adjustable housing interval has been modified to allow users to set the desired target negative pressure between 3 and 10 minutes. the display of the detected status in the form of a warning is visible beyond eas.

Device

HARTMANN VivanoTec® and ATMOS® S 042 NPWT negative pressure therapy units

Manufacturer

ATMOS MedizinTechnik GmbH & Co. KG