Events

Alerte De Sécurité sur (1) CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS)

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
    102
  • Date
    2001-07-20
  • 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
    The fda issued on july 20, 2001, a public health alert that warns health establishments of the potential for patient aggravations when cytogenetic gas cylinders are mistakenly connected to o2 supply systems, patients receive other gas, such as nitrogen, other than medical o2. fda received report on 7 orbits and 15 aggregates, over the last 4 years, related to the erroneal connection of hospital gas in intensive therapy units and domiciliary attention units.
  • Action
    ACTION REQUIRED: The FDA RECOMMENDS THAT ALL OPPORTUNITIES TO PROMOTE THE PROPER HANDLING OF HOSPITAL GASES, AS WELL, OF RELATED CYLINDERS AND CONNECTORS, ARE ACCEPTED. TO THE FOLLOWING: (1) WHEN CONNECTING A CYLINDER, CAREFULLY EXAMINE THE LABEL TO ENSURE THAT THE GAS CONTAINS THE GAS ADEQUATE TO ITS APPLICATION, TO AVOID POSSIBLE AGGREGATES ARISING FROM ERRONE CONNECTION OF HOSPITAL GAS CYLINDERS. (2) NEVER USE ADAPTERS OR CHANGE CONNECTORS OR PLUG IN A CYLINDER. IF A CONNECTOR DOES NOT JOIN THE O2 SUPPLY SYSTEM, PROBABLY THE GAS IN WHICH CYLINDER IS NOT O2 AND, THEREFORE, SHOULD NOT BE USED. (3) MAKE SURE THAT ALL PERSONNEL HANDLING HOSPITAL GASES ARE PROPERLY TRAINED AND UNDERSTAND THE OPERATIONS AND CONNECTIONS OF HOSPITAL GAS SYSTEMS AND LABELS. (4) IF YOUR ESTABLISHMENT RECEIVES BOTH HOSPITAL AND INDUSTRIAL GASES, STORE IN SEPARATE LOCATIONS. TO REPORT ADVERSE EVENTS RELATED TO HOSPITAL GASES, CONTACT THE MANUFACTURER OF THE CYLINDER, OR SEND CORRESPONDENCE TO ANVISA, ON THE INTERNET WWW.ANVISA.GOV.BR/TECNOVIGILÂNCIA/ FORMS OR BY THE E-MAIL TECNOVIGILANCIA@ANVISA.GOV.BR.

Device

(1) CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS)
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA