Events

Alerte De Sécurité sur micro-pace 4580

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

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
    2012-09-25
  • Date de publication de l'événement
    2012-09-25
  • 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_20120925a.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: pace medical micro-pace 4580 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning micro-pace 4580, manufactured by pace medical, inc. pace medical has observed in the ref 4580 that in a specific use of the device the defibrillation protection circuitry may not function as well as intended. if the device is used on a patient, with heart wires and the patient’s heart is defibrillated directly on the heart, there may be a chance that the device will be damaged from the defibrillation output current. the manufacturer has designed and validated a new defibrillation protection circuit which will eliminate the potential for this to occur. furthermore, it advised that: users should return the affected device for a complimentary upgrade. the device should not be used in cardiac surgical theaters where heart wires are used and defibrillation is applied directly to the heart tissue. ref 4580 can be used in other procedures while scheduling product return, but patients should be monitored while the device is in use and a backup device should be on hand. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185136 if you are in possession of the product, please contact your supplier for necessary actions. posted on 25 september 2012.

Device

micro-pace 4580
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pace Medical MICRO-PACE 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical