Events

Field Safety Notices about Resuscitation System and Mask Model

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Intersurgical Ltd.

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 Date Posted
    2018-02-13
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2018/02/13/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-rescucitaion-system-and-mask-model/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the 'back plate' of the self-inflating bag being orientated incorrectly.The incorrect orientation of the directional valves could result n the bvm manual system becoming over pressurised, which could result in patient barotrauma.

Device

Resuscitation System and Mask Model
  • Model / Serial
    7150000- 363791; 370252; 370751; 371638; 372887; 372894; 375508,7151000 -364909; 370253; 371091; 371639; 372886; 372890; 375711,7152000 -363792; 364270; 364923; 365216; 370266; 370752; 371640; 371656; 372888; 372889; 372893; 373638; 373639; 375411,7153000 -363793; 370738; 371907; 372892; 375509,7154000 -370753; 372367
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd