Events

Safety Alert for ASSEMBLY EQUIPMENT FOR: (1) CONTRAST INJECTORS, (2) EXPLANATION LIGHTS, (3) PHOTOTHERAPY UNITS, (4) RADIATION PROTECTORS IDENTIFIER:

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    128
  • Date
    2000-09-22
  • 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
    Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
  • Action
    ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM

Device

ASSEMBLY EQUIPMENT FOR: (1) CONTRAST INJECTORS, (2) EXPLANATION LIGHTS, (3) PHOTOTHERAPY UNITS, (...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA