Events

Field Safety Notices about Puma, Beatle, Alex & Ibis XP Power Wheelchairs

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Handicare.

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
    SN2014(04)
  • Date
    2014-02-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/puma-beatle-alex-ibis-xp-power-wheelchairs&id=d778f825-9782-6eee-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
    Handicare has identified a potential issue with the compact lights on puma, beatle, alex and ibis xp power wheelchairs. the lights might cause overheating and as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare and healthcare 21 have successfully exchanged 33 units of the 87 placed on the irish market. there are 54 units in ireland which cannot be located and require an exchange.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have any affected power wheelchairs, please stop using the front and rear light (blinkers can still be used) and contact your local dealer or Healthcare 21.

Device

Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Model / Serial
  • Product Description
    Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Manufacturer
    Handicare

Manufacturer

Handicare