Events

Alerte De Sécurité sur UROLOGICAL TABLES

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    101
  • Date
    2001-06-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA