Events

Field Safety Notices about BVM (Bag-Valve-Mask) Manual Resuscitation Systems

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 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
  • Date
    2017-06-05
  • 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
    There is a possibility the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment. the instructions for use provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use. this field safety notice gives additional information relating to this specific problem and the additional actions required. .

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Model / Serial
    1. All lot numbers up to and including lot 370253 2. All lot numbers up to and including lot 1170673 3. All lot numbers up to and including lot 31753734 4. All lot numbers up to and including lot 170504
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd