Events

Alerte De Sécurité sur ClearSight Heart Reference Sensor

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

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
    2017-12-14
  • Date de publication de l'événement
    2017-12-14
  • 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_20171214.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: edwards lifesciences clearsight heart reference sensor medical device manufacturer, edwards lifesciences, has issued a medical device safety alert concerning its clearsight heart reference sensor [model number: evhrs; all serial numbers manufactured after 31 december 2015]. the current product as well as the affiliated labeling contains an expiration date of two years. through investigation and analysis of complaint data, the manufacturer discovered that hrs units are susceptible to experiencing an “hrs out of range” error message in the ev1000 platform that is beyond six months from the date of manufacture. as a result, the manufacturer has decided to change the expiration date to six months from the date of manufacture. additionally, this change will also require replacing the operator’s manual of the ev1000 clinical platform and the instructions for use (ifu) of the heart reference sensor. according to the manufacturer, this issue poses no risk to patients as the ev1000 clinical platform will not allow the clinician to zero the device and initiate monitoring. this would create a pre-procedural delay while the troubleshooting process is completed. affected users could continue to use the product. if the user does not encounter the “hrs out of range” message on the ev1000 clinical platform, the heart reference sensor is functioning properly and can be safely used to monitor your patients. if the user encounters the “hrs out of range” message on the ev1000 clinical platform, he/she should contact the manufacturer’s technical support. product replacement is on-going. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 december 2017.

Device

ClearSight Heart Reference Sensor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Edwards LifeSciences ClearSight Heart Reference Sensor
  • Manufacturer
    Edwards LifeSciences

Manufacturer

Edwards LifeSciences