Events

Alerte De Sécurité sur FRED easy

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Schiller Medical SAS.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-02-06
  • Date de publication de l'événement
    2017-02-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170206c.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: schiller medical sas fred easy the health sciences authority (hsa) has issued a medical device safety alert concerning fred easy, manufactured by schiller medical sas [reference: 4-07-0001; lot number hyb 16-0056, hyb 16-0057, hyb 16-0058 and hyb 16-0059; between october 1, 2016 and january 15, 2017]. according to the manufacturer, users have reported some new batteries causing the failure "battery empty" when inserted into a defibrillator fred easy. batteries with this fault cannot be used. the fault is detected automatically by the fred easy when the battery is inserted into the device. the batteries of these lots must be tested, using the procedure described below, to verify that they can be used in their fred easy: insert the battery into fred easy (see section 3.1 "inserting the battery" in the fred easy user manual). the unit performs its self-test. at the end of the self-test, it shuts down and its green led flashes: in this case, the battery is free from defects and can be used without limitation. however, if after the self-test of fred easy the green light remains off and the display shows: the battery is defective. in this case, contact schiller distributor immediately, to get replacement. for details, please refer to the hsa website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/january.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2017.

Device

FRED easy
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Schiller Medical SAS FRED easy
  • Manufacturer
    Schiller Medical SAS

Manufacturer

Schiller Medical SAS