Events

Alerta De Seguridad para HEWLETT-PACKARD STERILIZABLE DEFIBRILLATION OPERATORS: (1) MODEL M14986B, (2) MODEL M1748A

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AGILENT TECHNOLOGIES HEALTHCARE 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
    143
  • Fecha
    2000-06-13
  • 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
    An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
  • Acción
    ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.

Device

HEWLETT-PACKARD STERILIZABLE DEFIBRILLATION OPERATORS: (1) MODEL M14986B, (2) MODEL M1748A

Manufacturer

AGILENT TECHNOLOGIES HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA