Events

Alerta De Seguridad para Physio-Control, LIFEPAK 20e Defibrillator/Monitor

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
    2018-01-09
  • Fecha de publicación del evento
    2017-01-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180109b.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 20e defibrillator/monitor medical device manufacturer, physio-control, has issued a medical device safety alert concerning its lifepak 20e defibrillator/monitor [model/catalog numbers: 70507-xxxxxx, 99507-xxxxxx; lot number multiple]. the manufacturer is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off. according to the manufacturer, the failures are the result of the manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). this has the potential to result in a failure to deliver therapy to the patient and serious injury or death. the manufacturer has not received any adverse events reported as a result of this issue. the manufacturer will contact potential affected users to arrange for a device correction included the replacement of the power pcba. the customers are requested to follow the recommended daily operator’s checklist steps in accordance with lifepak 20e defibrillator/monitor operating instructions – section 7 – maintaining the equipment. if the users experience any of the symptoms described above, contact the manufacturer immediately to arrange servicing to your device. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2017.

Device

Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Manufacturer
    Physio-Control

Manufacturer

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