Events

Alerta De Seguridad para HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE

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 INC. 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
    31
  • Fecha
    2001-04-14
  • 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
    The data and time of the filed data (wav registry, trends analysis, events and alarm reviews) of the system with the b.00.23 version and b.01.06 of the software are frequently wrong, with the vic showing variations of date and time of some of my.
  • Acción
    ECRI RECOMMENDS THE FOLLOWING: (1) ALERT THE USERS OF THESE CENTRAL AND ALL RELEVANT STAFF OF THE PROBLEM REFERENCED ABOVE WITH THE AUTOMATIC SWITCH TAKES FOR THE ALARMS AND SOFTWARE VERSIONS. (2) CONTACT YOUR AGILENT TECHNICAL REPRESENTATIVE TO SCHEDULE THE SOFTWARE EXCHANGE BY UPDATING (VERSION C). (3) UNTIL THE NEW VERSION IS INSTALLED AND CHECKED, THERE ARE TWO POSSIBLE ALTERNATIVES TO ADMIT OR TRANSFER A PATIENT: 1A. OPTION - FOR USE AS A MONITOR OF THE BED OR TRANSMITTED BY TELEMETRY - 10. TURN OFF THE MONITOR AND REMOVE THE BATTERY OF THE TELEMETRY TRANSMITTER, BEFORE CONNECTING IT TO THE PATIENT; 2O. CONNECT THE PATIENT TO THE MONITOR OR TELEMETRY TRANSMITTER, TURN ON THE MONITOR OR INSERT THE BATTERY ON THE TELEMETRY TRANSMITTER AND ENSUIT OFF THE "WAIT" CHOICE ON THE CENTRAL STATION; 3O. IMMEDIATELY AFTER, ADMIT THE PATIENT TO VIC. A 2A. OPTION - FOR USE WITH LIGHT MONITOR ONLY - 10. BEFORE CONNECTING A PATIENT, PLACE THE MONITOR IN THE "WAIT" MODE AND ADMIT THE PATIENT TO THE VIC; 2O. CONNECT THE PATIENT TO THE MONITOR AND REACTIVATE THE MONITOR, MAKE SURE THE MONITOR IS NO LONGER IN THE "WAIT" MODE! ECRI PREFER RECOMMENDS 2A. OPTION WITH LIGHT MONITOR, THAT IT SEEMS TO INDICATE TIME AND DATE WITH LESS LEVEL OF VARIATION, WHILE IN 1A. OPTION, ANY INTERVAL BETWEEN CONNECTION AND ADMISSION TO VIC MAY ALLOW THE OCCURRENCE OF VARIATIONS.

Device

HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA