Events

Alerte De Sécurité sur Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Model: H3 + (Plus - CHEXXXXX) /// Lots: 115190255741/115190255742/115190255743/115190255744/115190255744/115190255746 / 115190255759/115190255760/115190255761/115190255763/115190255764/115190255767/115190255769/115190255770/115190255773/115190255777/115190255778/115190255779/115190255780/115190255787/115190255788/115190255789/115190255786/115190255800/115190255803/115190255804/115190255808/115190255809/115190255810/115190255814/115190255822 / 115190255823/115190255824/115190255826/115190255827/115190255830/115190255832/115190255833/115190255834/115190255835/115260261298/115260261299/115260261300/115260261301/115260261302/115260261303/115260261304/115260261305/115260261306/115260261307/115260261308/115260261309/115260261310/115260261311/115260261312/115260261313 / 115260261314/115260261315/115260261316/115260261317/115260261318/11 52602613119/15260261320/115260261321/115260261322/115260261323/115260261324/115260261325/115260261326/115260261327/115260261328/115260261329/115260261330/115260261331/115260261332/115260261333/115260261334/115260261335/115260261336/115260261337/115260261338/115260261339/115260261340/115260261341/115260261342/115260261343 / 115260261344/115260261346/115260261348/115260261349/115260261350/115260261351/115260261351/115260261352/115260261353/115260261354/115260261355 115260261356/115260261357.

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 TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc..

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
    1862
  • Date
    2016-04-08
  • 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
  • Cause
    According to tkl, "we received a field corrective action notice from the manufacturer" field corrective action notice "on 11/19/2015, reporting that it identified a problem with the hardware of the h3 + model equipment, which could result in a battery current higher than normal and cause the device to record less time than expected, requiring corrective repair of the equipment hardware. ".
  • Action
    The action is being taken due to the identification of a problem in the hardware of the H3 + model, which can result in a higher than normal battery current and cause the device to record less time than expected, requiring corrective repair action device hardware. a) Risk classification III; b) Classification of the field action: Correction in Field / Correction of parts and pieces / Other situation (IncisoIV); c) Field action code: 001.16; d) recommendations to users and patients: Segregate product for service repair.

Device

Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Mo...

Manufacturer

TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc.
  • Source
    ANVSANVISA