Events

Safety Alert for UROLOGICAL TABLES

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
    101
  • Date
    2001-06-30
  • 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
    An ecri member hospital reported a fire on a urological table, which probably occurred due to service materials (eg, documents, software, spare parts, tools) have been stored in a static proof in an electrical framework within the table and heat resulting from the circuit inflamated the plastic of the service materials and the stage-proofed bag.
  • Action
    ACTION REQUIRED: (NOTE: READ THE ORIGINAL REPORT BELOW UNDERSTANDING THE REASON FOR THE FOLLOWING RECOMMENDATIONS.) ECRI RECOMMENDS THAT: (1) ALERGE USERS, SERVICE PERSONNEL AND OTHER EMPLOYEE MEMBERS ON THE PROBLEM AND THE ECRI REPORT. (2) DO NOT STORE SERVICE MATERIAL INSIDE THE EQUIPMENT, UNLESS SPECIAL COMPARTMENT IS FOR SUCH MATERIALS. (3) SAVE THE SERVICE MATERIAL IN A CENTRAL SITE, AS DESCRIBED IN THE INSTALLATION EQUIPMENT CONTROL PROGRAM. (4) IF THE SERVICE MATERIAL HAS TO BE KEPT WITH EQUIPMENT WHICH DOES NOT HAVE AN APPROPRIATE SITE FOR STORAGE, ATTACH A PLASTIC COMPARTMENT OR CONTAINER ON THE EXTERNAL SIDE OF THE EQUIPMENT BOX. MAKE SURE THAT THE PLASTIC COMPARTMENT OR THE CONTAINER IS KEPT FROM AIR CIRCULATORS, CONTROL SURFACES, OR SURFACES THAT COULD BE CHARGED. FOR FURTHER INFORMATION, CONTACT RICHEMOND'S AL, ECRI, BY PHONE (610) 825-6000, RAMAL 5187.

Device

UROLOGICAL TABLES
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA