Events

Alerta De Seguridad para 12V 2,3 AH BATTERIES WITH ACID AND TRANSPORTATION LEAD MODEL AGILENT / HEWLETT-PACKARD 40488A. COMPONENTS USED ON M1205A V24 / 26CT MODELS OF THE AGILENT AND M1275A MONITORING SYSTEM OF THE HEWLETT-PACKARD TRANSPORT SYSTEM. CODES 990901 À 991231, 000101 À 000131, MANUFACTURED BETWEEN 1O. SEPTEMBER 1999 AND JANUARY 31, 2000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PANASONIC INDUSTRIAL MEDICAL GROUP E DISTRIBUÍDAS PELA AGILENT TECHNOLOGIES INC. HEALTH CARE SOLUTIONS GROUP.

¿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
    41
  • Fecha
    2001-05-04
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    After the 1o. low battery alarm - "recharge"! the batteries may not provide "at least 15 minutes" of patient monitor operation before deleting the monitor. agilent affirms that the models m1205a and m1257a operate normally on ac power, but can not be used for transportation unless they are connected to ac power. loss of time between the recharge battery alarm and the time to delete the monitor may not be sufficient to locate another energy source, resulting in transitional loss of monitoring data from the patient being transported. agilent started the voluntary removal day, april 25, 2001.
  • Acción
    MAKE SURE YOU HAVE RECEIVED AGILENT'S VOLUNTARY REMOVAL LETTER ON APRIL 25, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THESE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. PREPARE AN INVENTORY OF BATTERIES AFFECTED BY THE DATE PRINTED IN BLACK INK, NEAR THE ELECTRICAL CONTACTS, AND BY THE MODEL NUMBER OF THE BATTERY, LOCATED IN THE MIDDLE OF THE LABEL. MONITORS THAT HAVE AFFECTED BATTERIES CAN BE IDENTIFIED BY THE LABELS IN FRONT OF THE MONITORS. AGILENT WILL REPLACE FREE OF CHARGED BATTERIES. TO REPLACE THESE CONTACT YOUR AGILENT REPRESENTATIVE OR THE UNITED STATES NATIONAL NOTIFICATION CENTER (00XX-1-880-668-4391 OR 934-7372). LIDE AND DISPOSE OF BATTERIES ACCORDING TO THE REQUIRED STANDARDS, KEEPING THE TESTS.

Device

12V 2,3 AH BATTERIES WITH ACID AND TRANSPORTATION LEAD MODEL AGILENT / HEWLETT-PACKARD 40488A. CO...

Manufacturer

PANASONIC INDUSTRIAL MEDICAL GROUP E DISTRIBUÍDAS PELA AGILENT TECHNOLOGIES INC. HEALTH CARE SOLU...
  • Source
    ANVSANVISA