Events

Field Safety Notices about Contoura 880 Beds

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Huntleigh Healthcare 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
    2009-08-21
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contoura-880-beds&id=de8cf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
  • Action
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Contoura 880 beds.  3) Determine if your institution has devices affected by this issue.  This can be determined by:       A) Checking the manufacturing date to see if it is between December 1999 and June 2001.       B) Checking if the Serial number lies in the range 167386 to 382938.  4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.  5) Ensure that correction is completed on all affected devices.

Device

Contoura 880 Beds

Manufacturer

Huntleigh Healthcare Ltd