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
    2017-12-22
  • 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
    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 images show the incorrect and correct orientation of the directional valves. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • 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 7152005 – 31753284, 31756956, 31757575 7152006 – 31660106, 31753127, 31756716, 31757576, 31758289 7152007 – 371092 7152012 – 31753733, 31756957 7153000 – 363793, 370738, 371907, 372892, 375509 7153008 – 31753734 7154000 – 370753, 372367
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd