Events

Safety Alert Or Field Safety Notices for BVM (Bag-Valve-Mask) manual resuscitation systems

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Intersurgical.

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
    Safety alert / Field Safety Notice
  • Date
    2017-06-21
  • Event Date Posted
    2017-06-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/bvm-bag-valve-mask-manual-resuscitation-systems-risk-of-delay-to-emergency-treatment
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
  • Action
    Identify all affected devices – see details below. Search for alternative devices to replace affected products (see appendix), and until alternative devices are available follow the guidelines in the Field Safety Notice. Once you have alternatives, quarantine the affected devices and contact Intersurgical.

Device

BVM (Bag-Valve-Mask) manual resuscitation systems
  • Model / Serial
  • Product Description
    The following model (REF number) and LOT numbers are affected:REF number LOT number NHS Supply Chain Code 7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 All lot numbers up to and including lot 370253 7150000 is FDE656, 7152000 is FDE658, 7153000 is FDD4288 7152003 All lot numbers up to and including lot 1170673 n/a 7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 All lot numbers up to and including lot 31753734 n/a 7150170, 7151170, 7152170, 7152172, 7153170 All lot numbers up to and including lot 170504 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Manufacturer Address
    Chris Randall IntersurgicalTelephone: 0118 9656 362Fax: 0118 9656 356Email: priority@intersurgical.co.uk
  • Manufacturer Parent Company (2017)
    Etablissement Cosmeplast
  • Source
    MHRA