Events

Alerte De Sécurité sur Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 / US914B0277.

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.; Philips Medical Systems Nederland B.V..

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
    1585
  • Date
    2015-05-13
  • 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
    According to the company, if a health care provider makes a clinical decision based on a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy. ///// ** this action will be implemented in conjunction with 2 other FCOs reported: FCO79500336- Epiq 5 (Pediatric Conversion Correction) FCO79500337- Epiq 7 (Pediatric Conversion Correction).
  • Cause
    According to the record holder there is an error in the conversion of the unit weight and height, in the metric setting, in the calculation for the patient's body surface area that results in incorrect calculation.
  • Action
    The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. Philips corrected this problem in versions 1.3.3 and higher. If you have a software version affected, contact your local Philips representative to schedule an upgrade of your software. Note: If Pediatric Cardiology is enabled, please contact your local Philips representative urgently to schedule an update of your software in accordance with FCO79500337. Until your software can be upgraded, the situation can be avoided by ensuring that the Patient Data Units setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the "Metric" units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen before including an examination. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before loading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 ...

Manufacturer

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