Events

Alerta De Seguridad para Uninterruptible Power Supply (UPS) - Used in Philips equipment; Brand Philips; registration of the affected products: 10216710106; 10216710170; 10216710232; 10216710134; 10216710267; 10216710196; 10216710218; 10216710177; 10216710189; 10216710277; 10216710168; 10216710193; 10216710197; 10216710191; 10216710209.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1546
  • Fecha
    2015-03-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    This may be due to non-preventive maintenance or periodic battery replacement. The risks involved in the failure of the device are: chemical or thermal burns and irritation in the eyes, nose or throat. #### UPDATED 7/18/2017, the company sent a field action completion report, foreseen.
  • Causa
    Ups devices fail (uninterruptible power supply) resulting in battery acid leakage, overheating or smoke emission. all ups devices with lead acid batteries are susceptible to this problem.
  • Acción
    According to the registration holder's instructions, the customer should analyze the contents of the folder and implement a UPS maintenance program as recommended by the manufacturer of his UPS. /// If you notice any unusual odor and / or heat, or see any liquid in the UPS area, do not touch the device or the surrounding liquid. Follow your institution's procedure for potentially hazardous materials. Inform all persons in the vicinity of this potentially dangerous situation, including but not limited to - patients, staff and maintenance personnel. Contact your service provider immediately.

Device

Uninterruptible Power Supply (UPS) - Used in Philips equipment; Brand Philips; registration of th...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA