Events

Alerte De Sécurité sur Patient Data Manager and Origin Data Management

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

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
    2015-09-29
  • Date de publication de l'événement
    2015-09-29
  • 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_20150929b.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: brainlab patient data manager and origin data management the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning patient data manager and origin data management manufactured by brainlab. the affected devices are identified as follows: content manager (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0); patient browser (versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.1.0) and dicom viewer (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0). according to the alert, when users actively deselect a fused reference dataset in content manager (the default setting is “selected”), a contained point, object or trajectory may appear shifted and/or distorted in the subsequently used brainlab navigation or planning software. if a reference dataset is deselected and the error occurs, the magnitude of shift or distortion varies, depending on the differences between the two datasets. therefore, for some cases, the shift or distortion will be clearly visible when the plan is used in a brainlab planning or navigation system. however, a shift could also be non-obvious. if a shift or distortion occurred and was not detected during review of the data, the deviation of the information displayed in the brainlab planning or navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient. for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-21-to-25-september-2015 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 29 september 2015.

Device

Patient Data Manager and Origin Data Management
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab Patient Data Manager and Origin Data Management
  • Manufacturer
    Brainlab

Manufacturer

Brainlab