Events

Safety Alert for AGILENT INFORMATION CENTER (BEFORE HEWLETT PACKARD VIRIDIA INFORMATION CENTER) MONITORING SYSTEMS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    33
  • Date
    2001-04-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Reported case of sound alarm failure in the central above, the patient was connected to a telemetry transmitter. in inspection, it was found that the outlet that connects the two independent alarm speakers with the central processing unit.
  • Action
    THE MANUFACTURER AFFIRMS THAT THE INSTALLATION MANUAL ALERT THAT THE SPEAKER WIRE WILL NOT BE DISCONNECTED BY ACCIDENT. ECRI RECOMMENDS THE FOLLOWING: (1) ALERT THE USERS OF THESE CENTERS AND ALL PERSONAL RELEVANT TO THE PROBLEM CITED. (2) MAKE SURE THAT THE SPEAKER OUTLET IS CONNECTED PROPERLY TO THE UNIT. (3) CONTACT YOUR AGILENT TECHNICAL REPRESENTATIVE TO HAVE A SUPPORT SOCKET INSTALLED. HOWEVER, TO AVOID ACCIDENTAL FRICTION, ATTACH WITH A WIRE OR WITH A NECKLACE OF ELECTRICAL CABLES WITH SCREWS.

Device

AGILENT INFORMATION CENTER (BEFORE HEWLETT PACKARD VIRIDIA INFORMATION CENTER) MONITORING SYSTEMS

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA