Events

Field Safety Notices about Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by YSM Medical & Rehabilitation Equipment 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
  • Event Number
    SN2009(12)
  • Date
    2009-12-10
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/oxy-top-5-oxy-tec-5-oxygen-concentrator&id=548cf825-9782-6eee-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
    Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
  • Action
    Advice for Retailers and Wholesalers  (1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.  (2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  (3) Ensure the appropriate personnel are made aware of this notice.  Advice for Healthcare Institutions / Consumers  (1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.  (2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.  (3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.  (4) Ensure the appropriate personnel are made aware of this notice.

Device

Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

Manufacturer

YSM Medical & Rehabilitation Equipment Ltd
  • Source
    HPRA