Events

Alerte De Sécurité sur EXTERNAL DEFIBRILLATORS: LIFEPAK 1000 (Anvisa Reg. 10339190300). UNITS MANUFACTURED IN 2007.

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 Physio-Control Inc.; Medtronic Comercial 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
    931
  • Date
    2008-07-01
  • 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
    According to Medtronic Commercial Ltd., the defibrillators described above were fabricated with a component that may fail due to a higher electrical leakage than normal in this item, which can cause the display to weaken and possibly the total disappearance of the data. The devices identified were manufactured in a limited number between January and December 2007 and the company said it considers it unlikely after an engineering review that the display or performance of LIFEPAK 1000 is affected by this problem. As an additional check the company is running functional tests to confirm the engineering analysis.
  • Cause
    Possibility of failure of the equipment display.
  • Action
    Users should identify any risk-defibrillators they may have, but may continue to use them normally. It is recommended that devices be set to "auto-analyze" mode by selecting "analyze" in the device menu. If you detect that the information on the LIFEPAK 1000 defibrillator display begins to weaken or disappear completely, you must inform the product registration holder in Brazil immediately (Medtronic Comercial Ltda - Tel: (11) 2182-9200). If the display erases during use, the recommended measures are as follows: (1) Continue to use LIFEPAK 1000 to treat the patient (voice and sound messages work normally); (2) If the equipment is not set to "auto-analyze," use the right-hand key at the bottom of the screen to select Analyze.

Device

EXTERNAL DEFIBRILLATORS: LIFEPAK 1000 (Anvisa Reg. 10339190300). UNITS MANUFACTURED IN 2007.

Manufacturer

Physio-Control Inc.; Medtronic Comercial Ltda.
  • Source
    ANVSANVISA