Events

Alerte De Sécurité sur Trade Name: VENTILATION SYSTEM 840 # Registration: 10349000386 -. Risk Class: III - HIGH RISK # MODELS 4-072214-00; G-062010-00. The series under risk in Brazil and the respective client are in Annex 1.

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 AUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.; NELLCOR PURITAN BENNETT IRELAND.

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
    1355
  • Date
    2014-02-14
  • 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
    Complaints have been received from clients in which they declare that the O2 sensor inside the ventilator is not working and that they need to move a patient from one ventilator to another surrogate mechanical ventilation. • If a sensor becomes nonfunctional during use and can not be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied oxygen level of the ventilator and provide the appropriate alarms. o A non-functional O2 sensor does not affect the oxygen concentration supplied by the fan and does not control the flow of gases. • If a sensor becomes non-functional and the institution's protocol requires the transfer of a patient to a surrogate ventilator, the patient should be clinically evaluated to determine the best transfer conditions to reduce patient risk. - According to information of the company the Field Action was completed.
  • Cause
    Conflicting information was provided to puritan bennett 840 fan customers in an addendum to the label (p / n 066009a 09/02) stating that the oxygen sensor should be replaced every two years. the correct operational life is one year from the manufacturing date, as stated in the puritan bennett 840 fan operator's manual. the sensor, p / n 4-072214-00, must not be used after the expiration date printed on the oxygen sensor packaging. puritan bennett 700 series fan operator and service manuals also state that the oxygen sensor should be replaced every two years. the sensor, p / n g-062010-00, should not be used after the expiration date printed on the oxygen sensor package.
  • Action
    Company is submitting to its customers document with label update (Annex 2)

Device

Trade Name: VENTILATION SYSTEM 840 # Registration: 10349000386 -. Risk Class: III - HIGH RISK # M...

Manufacturer

AUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.; NELLCOR PURITAN BENNETT IRELAND
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA