Events

Alerte De Sécurité sur Trade name: Optima MR430S Magnetic Resonance Imaging System (Model: Optima MR430S 1.5T); ANVISA record: 80071260327; risk class II; lots / series (place of distribution): MR04082010 (São Paulo-SP); MR05072010 (Brasília-DF); MR07082010 (Vitória-ES); MR07092010 (Goiânia-GO); MR11242009 and MR12142009 (Curitiba-PR); MR12152009 (Florianópolis-SC) /// Model: DISCOVERY MR450, ANVISA registration: 80071260116.

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 GE Healthcare do Brasil; GE MEDICAL SYSTEMS LLC.

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
    1898
  • Date
    2016-05-20
  • 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
    Users should notify GEHC Maintenance Engineers if the Magnet Monitoring Unit (MMU) detects any abnormal or out-of-spec reading. If the Magneto Monitoring Unit (MMU) detects an error, it will display a pop-up window on the system monitor, which will be seen by the operator. The errors shown by the MMU will be in the format: error CAS7XX (being XX, the specific error) with a brief description. If no error is shown on the Magneto Monitoring Unit, no action is required. Affected products can continue to be used normally. If you have any questions about this security alert please call: Metropolitan Capitals and Regions 3004 2525 and Other regions: 0800 165 799 UPDATE ON JUNE 6, 2016, FOR THE INCLUSION OF THE DISCOVERY MR450 MODEL, ANVISA registry: 80071260116. field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Cause
    One facility reported to ge on february 21, 2016, about a magneto quench event with subsequent release of cryogen gas into the magnet room. at this facility, the magneto heater probe connection disconnected. this resulted in the accumulation of ice inside the magnet, blocking the venting of the cryogen. as the ventilation was blocked by ice, the quench back of the magnet caused the gas to be released into the magnet room. the occurrence of the fault described in this notification can generate ice accumulation inside the magnet, blocking the cryogenic ventilation, which may cause the cryogenic gas to release into the magnet room. this release may result in a critical oxygen deprivation for users and patients. however, the danger situation is detectable due to the intense sound generated by the magneto quench, allowing the opportunity for evacuation or response of the emergency professionals before the occurrence of an injury.
  • Action
    IMF action code 60899. Letter to clients ///// Parts / Parts Correction

Device

Trade name: Optima MR430S Magnetic Resonance Imaging System (Model: Optima MR430S 1.5T); ANVISA r...

Manufacturer

GE Healthcare do Brasil; GE MEDICAL SYSTEMS LLC