Events

Safety Alert Or Field Safety Notices for Cook Vacuum Pump for IVF

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 Cook Medical.

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
    2018-05-24
  • Event Date Posted
    2018-05-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/cook-vacuum-pump-for-ivf-risk-of-electric-shock-or-burn-to-operator
  • 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
    The manufacturer identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0.The potential hazardous situations which could arise as a result of this include; failure of the device to operate or electric shock or burn to the user.
  • Reason
    Manufactured by cook medical – risk of electric shock or burn, and failure of the device to operate during ivf procedures because of non-compliant mains wiring.
  • Action
    Identify the affected devices as stated in device details and, in the manufacturer’s, Field Safety Notice (FSN). Ensure that all users receive the manufacturer’s FSN and that they understand the problem. Ensure a residual current device (RCD), which is marked stating its compliance with BS 7071, is fitted to the mains electricity supply to mitigate the risk of a hazardous situation. RCDs are also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI). If you do not have access to an RCD (or equivalent) do not use the vacuum pump until the mains wiring for the unit has been replaced by the manufacturer. If an adverse event occurs relating to this issue please report this to the MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

Cook Vacuum Pump for IVF
  • Model / Serial
  • Product Description
    Product Name Reference Part Number Global Product Number Lot Numbers Cook Vacuum Pump™ K-MAR-5200 G49275 All lots
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical
  • Manufacturer Address
    Cook Medical Ms. Sinead BurkeTel: +353 (0)61 334440Sinead.burke@CookMedical.com
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    MHRA