Events

Safety Alert Or Field Safety Notices for Headrest attachment to operating tables

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 Maquet 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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2011/075
  • Date
    2011-07-06
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-headrest-attachment-to-operating-tables-confirm-actions-after-receipt-of-field-safety-notice
  • 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
    Concerns about the safe use of a headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0.The manufacturer issued a Field Safety Notice (FSN) for this device on 12 May 2011 (1709Kb) but has not had sufficient confirmation from users that they have received and acted on this information.This alert has been issued in support of the manufacturer’s actions.
  • Reason
    (maquet ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65a0 and 1002.65s0. (mda/2011/075).
  • Action
    Ensure that relevant members of staff are aware of the problem. Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Device

Headrest attachment to operating tables
  • Model / Serial
  • Product Description
    Headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0 manufactured by Maquet Ltd.
  • Manufacturer
    Maquet Ltd

Manufacturer

Maquet Ltd
  • Manufacturer Address
    Colin Moralee Maquet Ltd Tel: 0191 519 6200 Fax: 0191 519 6201Email: cmoralee@maquet.co.uk
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    MHRA