Events

Alerta De Seguridad para : PHOTOTHERAPY SYSTEMS: (1) MODEL PTL68, (2) MODEL PTM78, (3) MODEL PTS68; (4) PHOTOTHERAPY SYSTEM LAMPS. PARTS: (1 to 3) UNIDENTIFIED, (4) 1780745

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HILL-ROM AIR-SHIELDS A HILLENBRAND CO.

¿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
    119
  • Fecha
    2000-09-29
  • 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
    PRODUCT REGISTERED IN BRAZIL ON 06.05.1999 (INSTRUCOM). HOWEVER, UNTIL THIS DATE, STILL HAS NO MARKETING REGISTRATION. INSTRUCOM COMMUNICATES AS SOON AS THE PRODUCT WILL BE EXECUTED, YOU WILL CLARIFY YOUR CUSTOMERS OF THE FACT THAT HAPPENED, A WAY TO GUARANTEE THE QUALITY OF THE PRODUCT. WHEREVER, THEY HAVE ORIGINAL AND PROFESSIONAL REPLACEMENT PARTS QUALIFIED WITH TRAINING BY PROPRIET MANUFACTURER.
  • Causa
    Hill-rom air-shields edited a product service bulletin disclosing that the company received information that hospitals are replacing the phototherapy system lamps by non-authorized lamps, not compatible by the hill-rom . the phototherapy systems mentioned incorporate lamps with a specific reflector. air-shields hill-rom ends that systems operating without this reflector can generate more heat / energy in the light beam, which could cause equipment failures and commit patient and employee safety.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED AIR-SHIELDS HILL-ROM PRODUCT SERVICE BULLETIN. REPLACE LAMPS ON PHOTOTHERAPY SYSTEMS MENTIONED ONLY BY NO. 1780745, WHICH ARE AS SPECIFIED BY HILL-ROM SERVICE MANUALS. INSTRUCTIONS ON THE REMOVAL AND REPLACEMENT OF THE LAMPS MAY ALSO BE FOUND IN SERVICE MANUALS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR AIR-SHIELDS HILL-ROM REPRESENTATIVE OR PHONE 1 (215) 675-5200 IN THE UNITED STATES.

Device

: PHOTOTHERAPY SYSTEMS: (1) MODEL PTL68, (2) MODEL PTM78, (3) MODEL PTS68; (4) PHOTOTHERAPY SYSTE...

Manufacturer

HILL-ROM AIR-SHIELDS A HILLENBRAND CO
  • Source
    ANVSANVISA