Events

Alerte De Sécurité sur LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174.

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 Mallinckrodt do Brasil Ltda..

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
    1007
  • Date
    2010-02-24
  • 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
    According to the record holder, the internal batteries (in conjunction with the battery system controller) may cause the internal battery controller to trigger the safety mode of the equipment and, as a consequence, turn on a high priority alarm. In this case the alarm would be triggered unnecessarily, which can lead to an incorrect decision making on the part of the users. Anvisa's Technovigilance Unit is following up on this case. #### UPDATE (07/04/2011): The company sent a communication to UTVIG / ANVISA (Expediente: 585270 / 10-6) informing the finalization of corrective actions. According to the company, all equipment at risk in Brazil (36 units) were corrected (battery replacement). The company sent copies of the Service Orders corresponding to the correction services. Related documents: NOTIVISA 2010.04.000814, Files 054579 / 10-1 and 585270 / 10-6.
  • Cause
    Failure associated with the battery and battery control system may cause undesired high priority alarm.
  • Action
    The record holder is replacing all revision D and E batteries used in LEGENDAIR ventilators. To the users of the product it is recommended: (1) Check the battery revision of your equipment; (2) If the equipment battery is in revision D or E, fill out the Battery Inspection Form and send it to the product registration holder. To access the Inspection Form and the detailed instructions on how to perform the battery check, see Appendix A of the alert on the UTVIG website (www.anvisa.gov.br/tecnovigilância/alertas).

Device

LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174.

Manufacturer

Mallinckrodt do Brasil Ltda.