Events

Alerte De Sécurité sur ABP Monitor, Model 90217A

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Spacelabs 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
    2011-11-15
  • 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_20111115a.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
    Mhra fsn safety alert: spacelabs healthcare abp monitor, model 90217a the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on ambulatory blood pressure monitor, model 90217a, manufactured by spacelabs healthcare. the manufacturer has identified a potential error code associated with the use of the product. if external pressure is applied to the cuff during deflation, the monitor will cease to function and display an ec75 error code. according to the manufacturer, there have been no injuries associated with this issue. spacelabs healthcare suggests the users to cycle the power off if error code is observed. the manufacturer is in the progress of upgrading the software. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

ABP Monitor, Model 90217A
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare