Events

Field Safety Notices about Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Corona 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
    Field Safety Notice
  • Event Number
    SN2011(29)
  • Date
    2011-11-28
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/corona-medical-bed-side-rails-1025-1031-sp-1027-range&id=3681f825-9782-6eee-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
    Corona medical bed side rails – 1025, 1031 & sp 1027 range are not compliant with the dimensional requirements of the applicable standards, which defines the minimum size and / or maximum areas with risk of trapping in an adult bed for medical use. these side rails require replacement.
  • Action
    Corona Medical and MMS Medical have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.  The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected side rails.  3. Determine if you / your institution have medical devices affected by this issue.  4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that corrective action is completed on all affected medical devices.

Device

Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Model / Serial
  • Product Description
    Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Manufacturer
    Corona Medical

Manufacturer

Corona Medical
  • Manufacturer Parent Company (2017)
    Hacare
  • Source
    HPRA