Events

Safety Alert Or Field Safety Notices for SLE 4000/5000 ventilator, Power supply unit (PSU) model FP110-410

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 SLE.

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 ID
    MDA/2013/054R
  • Event Number
    CON297494
  • Date
    2013-07-23
  • Event Date Posted
    2013-07-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297494?tabName=allTabs
  • 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
    Potential component failure in the power supply unit (psu). failure of the psu will cause the ventilator to alarm and shut down immediately. the manufacturer issued a technical bulletin to its customers in february 2012, recommending replacing the psu. however, the mhra is uncertain whether corrective actions were carried out.
  • Action
    Locate all affected ventilators and inspect them to identify affected PSUs. Contact the manufacturer for a replacement PSU as soon as possible if the original PSU has not already been replaced. Inform SLE when the PSU has been changed or if the ventilator is not affected. Have an alternative ventilator on standby until any faulty PSUs are replaced. Check supplies to ensure that any spare PSUs are not affected.

Device

SLE 4000/5000 ventilator, Power supply unit (PSU) model FP110-410
  • Model / Serial
  • Product Description
    SLE 4000/5000 ventilator. Power supply unit (PSU) model FP110-410. Specific serial numbers. Affected products can be identified as shown below: Affected product Ventilator model SLE 4000: Serial numbers 42040 and below Ventilator model SLE 5000: Serial numbers 53164 and below Power supply unit model FP110-410: Serial numbers from 163746 to 167558 inclusive Other model FP110-410 PSUs outside the above serial range may be affected if they contain ‘tall’ capacitors. These can be checked by following the recommendations in the manufacturer’s technical bulletin .
  • Manufacturer
    SLE

Manufacturer

SLE