International Medical Devices Database

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
Netherlands
Event Source
IGJ
Event Source URL
https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/06/5/field-safety-notice-intersurgical-bvm-bag-valve-mask-manual-resuscitation-systems
Notes / Alerts

The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Extra notes in the data
Reason
There is a possibility the valve of the bvm manual resuscitation system may become stuck during storage.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Model / Serial
Manufacturer
Intersurgical

Manufacturer

Intersurgical

Manufacturer Parent Company (2017)
Etablissement Cosmeplast
Manufacturer comment
Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
Source
IGJ

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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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

What is this?

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Manufacturer

Intersurgical