Events

Alerte De Sécurité sur IntelliCuff Standalone

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

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
    2017-06-12
  • Date de publication de l'événement
    2017-06-12
  • 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_20170612.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: hamilton medical ag intellicuff standalone medical device manufacturer, hamilton medical ag, has issued a medical device safety alert concerning its intellicuff standalone. the model number involved is pn 951001 and the affected serial numbers are from 1000 to 2090. the manufacturer’s analysis of a customer complaint has identified an issue relating to the performance of the motor in the intellicuff standalone device. during use, the motor may cease to function. the alarm sounds and the red leds blink in all segments. the intellicuff standalone must be switched off to silence the alarm. the number of failures is unacceptably high causing nuisance alarms and customer complaints. according to the manufacturer’s assessment, there is no risk for the patient or user related to this failure. product recall and replacement is on-going. the manufacturer will provide the necessary hardware improvements for intellicuff standalone devices. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 june 2017.

Device

IntelliCuff Standalone
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hamilton Medical AG IntelliCuff Standalone
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG