Events

Alerte De Sécurité sur 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors

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

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
    2013-04-26
  • Date de publication de l'événement
    2013-04-26
  • 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_20130426a.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: bayer healthcare 25-foot dc power cables shipped with medrad veris mr vital signs monitors medical device manufacturer, bayer healthcare, has issued a field safety notice concerning 25-foot dc power cables shipped with medrad veris mr vital signs monitors between february 2009 and february 2013 (catalogue number 3010556). according to the manufacturer, the affected power cables are being recalled due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. when the dc power supply is connected to both ac power (wall outlet) and the dc power cable, excessive heating of the dc power cable may occur. the manufacturer advises users to have visual inspection of the dc power cable against recall criteria provided by the manufacturer. the affected dc power cables confirmed by visual inspection will be replaced with new dc power cables. in the interim, users can still use the dc power cables by following instructions for safe use of dc power cable provided by manufacturer. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bayer HealthCare 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Manufacturer
    Bayer HealthCare

Manufacturer

Bayer HealthCare
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DH