Events

Alerte Ou Avis De Sécurité sur S74 Elite Sport Scooter with Leoch 20 amp/hour batteries

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Pride Mobility Products Ltd.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/013
  • Numéro de l'événement
    CON409261
  • Date
    2014-04-28
  • Date de publication de l'événement
    2014-04-28
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON409261?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Risk of the scooter batteries overheating and swelling during the charging cycle.  this may result in a reduced range of travel or a failure of the scooter to drive as expected. pride mobility products ltd has identified that the overheating and swelling is caused by a manufacturing fault with the batteries. pride mobility products ltd issued a field safety notice in february 2014. however, it is not clear whether users have received and acted upon this information.
  • Action
    Identify all users and staff responsible for users of S74 scooters and ensure that they receive the consumer letter attached to the manufacturer’s FSN. All users should contact their dealer for replacement batteries. Action by: All those involved in the provision, prescription and use of scooters.

Device

S74 Elite Sport Scooter with Leoch 20 amp/hour batteries
  • Modèle / numéro de série
  • Description du dispositif
    S74 Elite Sport Scooter with Leoch 20 amp/hour batteries Specific serial numbers. The following serial numbers are affected. SG211113017FVO – SG211113148FVO inclusive SG216713002FVO – SG216713169FVO inclusive SG219313286FVO – SG219313335FVO inclusive SG219313114FVO – SG219313211FVO inclusive
  • Manufacturer
    Pride Mobility Products Ltd

Manufacturer

Pride Mobility Products Ltd