Events

Alerte De Sécurité sur Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit

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
    2017-09-05
  • Date de publication de l'événement
    2017-09-05
  • 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_20170905.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 hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has issued a medical device safety alert concerning hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit, manufactured by hamilton medical ag. the analysis of a customer complaint has identified an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. the battery fuel gauge may indicate a higher battery charge as to what is available. the technical failure 444001"low battery" high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode. according to the manufacturer, when batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode. the alarm is triggered in every case to alert medical staff. the affected users are instructed to take the following actions:- the operator should make themselves familiar with the batteries' manufacturing date and react in time if battery is more than two years old. any battery with a manufacturing date to two years prior to the current date should be replaced. if the battery is less than two years old, return battery to slot, pushing until clip clicks into place, locking in the battery. use a screwdriver to lock metal clip back into place over battery. close battery door. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-29-august-to-1-september-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 september 2017.

Device

Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hamilton Medical AG Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG