Events

Alerta De Seguridad para Physio-Control LIFEPAK 1000 Defibrillator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Physio-Control.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-06-06
  • Fecha de publicación del evento
    2014-06-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140606.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: physio-control lifepak 1000 defibrillator the united states food and drug administration (fda) has issued a medical device safety alert concerning lifepak 1000 defibrillator [affected battery part number: 320371500xxx], manufactured by physio-control, inc. the manufacturer has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. a software malfunction in the lifepak 1000 defibrillator causes the readiness display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. the manufacturer advises users that batteries at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the "ok" symbol is present. users should always carry a spare fully-charged battery, as stated in the operating instructions. the manufacturer continues to investigate this issue and will have a follow up communication with users regarding this issue. this communication may include updates to operating instructions, software updates or additional maintenance instructions. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1660-2014&w=06042014&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 june 2014.

Device

Physio-Control LIFEPAK 1000 Defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Physio-Control LIFEPAK 1000 Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH