Events

Alerte De Sécurité sur Brand Name: External Automated Defibrillator Registration. Technical name: EXTERNAL AUTOMATIC / SEMI-AUTOMATIC DEFIBRILLER. ANVISA registration number: 80102511545. Risk class: III - High Risk. Affected Model: LIFEPAK 1000

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 VR MEDICAL LTDA; Physio-Control, 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
    2060
  • Date
    2017-01-19
  • 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
    The company is contacting customers and advising them to immediately remove and reinstall the battery of their device (s). Customers are also being advised to implement a weekly battery removal and reinstallation schedule for all LIFEPAK 1000 devices. Removal and reinstallation of the battery will clean the oxidation contacts and reduce the likelihood of this problem occurring. Physio-Control will initiate a hardware device fix for all affected LIFEPAK 1000 devices and the company that owns the registry in Brazil (VR Medical) will contact customers to schedule device fixes as soon as the hardware fix is ​​ready for implementation. WARNING: The company Medtronic Comercial Ltda also has the registered product (10339190300) - SEE ALERT 2059 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Health Surveillance should be done through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    The manufacturer company received 34 reports where customers tried to use their lifepak 1000 defibrillator and the device was shut down unexpectedly due to an intermittent connection between the battery and the electrical contacts of the device. a defibrillator in this setting may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious injury or death. the company is aware of 8 adverse events related to this issue. the company has determined that this intermittent bond is a result of wear and subsequent oxidation formation between the battery and the electrical contacts of the device. this condition may occur over time on lifepak 1000 devices that are exposed to vibration and have a battery installed for extended periods of time. this problem can potentially affect any lifepak 1000 device, however, customers with non-rechargeable batteries who do not routinely remove the battery for inspection as outlined in the lifepak 1000 defibrillator operating instructions are more susceptible to this problem. a defibrillator in this setting may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious injury or death. the company is aware of 8 adverse events related to this issue, registered in other countries.
  • Action
    Field Action Code AC01-17 triggered under the responsibility of the company VR MEDICAL LTDA. Sending guidelines on care involving maintenance of equipment.

Device

Brand Name: External Automated Defibrillator Registration. Technical name: EXTERNAL AUTOMATIC / S...

Manufacturer

VR MEDICAL LTDA; Physio-Control, Inc.
  • Source
    ANVSANVISA