Events

Alerte De Sécurité sur BrightView XCT Image System, Registration No. 10216710189, Serial Nos: 6000109, 6000115, 6000126, 6000276.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda..

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
  • ID de l'événement
    1307
  • Date
    2013-10-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The company informs that if the FDP unexpectedly unlocks, it can potentially contact the patient, the operator or the service personnel if they are in the path of the FPD. The severity was classified as "results in serious harm" and the likelihood of recurrence was classified as "not expected".
  • Cause
    Philips received a report from the field that the fpd was not firmly locked in the lodged position. a warning system message appeared warning the user that the fpd was unlocked. according to the project, the unlocking of the fpd caused the activation of the electronic stop by the system. in an attempt by the operator to eliminate the warning message while in the 0 degree position, the fpd has moved out of the lodged position.
  • Action
    Philips Healthcare is advising the customer / user to keep the FPD in place until the appropriate field safety correction is implemented. The following seven Pre-Programmed Movements (PPMs) can not be performed with the FPD positioned and are therefore unavailable until the field security correction is implemented: i. Bed Imaging (Mega-Body Scan), ii. Subsequently, iii. Seated Plantar, iv. Outer Room, v. DH Hands, vi. DH Sitting, vii. DH Standing. The following two PPMs must be performed with the FPD housed, so the operator must be careful: • Collimator exchange - To make a collimator change, the operator must first house the FPD. There should be no patient present during the collimator change as instructed in the Instructions for Use. • Intrinsic QA - This PPM requires that the FPD be in the housed position. There should be no patient present during the intrinsic QA. In addition, if the FPD unlocks without this being intended by the user in any position except the +90 degree position, a system warning will appear informing the user that the FPD is unlocked and that all movement will cease. • If the system is in clinical use at the time the warning message appears, the user must manually remove the patient from the area before attempting to lock the panel again. Refer to the current System Use Instructions Manual, "Removing a Patient from Gantry during an Emergency." • The user is instructed not to attempt to position or place the FPD in any position except the +90 degree position. Refer to the WARNING message located in the Flat Panel X-ray Detector (FPD) section of your current system INSTRUCTION MANUAL. Please refer to the Safety Notice letter attached to this alert.

Device

BrightView XCT Image System, Registration No. 10216710189, Serial Nos: 6000109, 6000115, 6000126,...

Manufacturer

Philips Medical Systems Ltda.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA