Events

Alerte De Sécurité sur Ambu Resuscitation, Self-Inflating, Manual

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
    372
  • Date
    2002-02-01
  • 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 medical devices agency (mda / uk) issued a safety alert upon receipt of an incorrect reassembly report from the manual resuscitator, which rendered them ineffective in emergency situations. mda states that various components of these appliances have been incorrectly positioned, and valves have been reversed.
  • Action
    MDA recommends the following care: (1) The Manual Resuscitator should only be cleaned and reassembled by appropriately trained personnel following the manufacturer's instructions. (2) During cleaning, the resuscitator must be thoroughly checked (checked) for correct operation. (3) The Manual resuscitator should only be used by individuals who have received adequate training. MDA states that Medical Devices Controls Assurance Standards practice guidelines should be followed and these current / current standards are available on the Internet at http://www.casu.org.uk. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485. Comments: ECRI also wrote about this problem (testing reuse of manual resuscitators). Health Devices August 28, 1999 [8]: 323). Also, note that MDA says that Manual Resuscitators that are inadequate will not work, but also, according to ECRI's warning, can cause harm to patients when resuscitators are handled or reassembled improperly. As a result, ECRI suggests that these products be checked for proper operation prior to each use. Comments: This incident is based on information from the MDA vendor that may not be independently verified with respect to the accuracy or causal relationship with specific products or vendors.

Device

Ambu Resuscitation, Self-Inflating, Manual
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA