Events

Alerta De Seguridad para LifeVest 4000 Wearable Cardioverter Defibrillator

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

¿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
    2018-01-18
  • Fecha de publicación del evento
    2018-01-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180118.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: zoll lifevest 4000 wearable cardioverter defibrillator the food and drugs administration (fda), united states posted a medical device safety alert concerning lifevest 4000 wearable cardioverter defibrillator, manufactured by zoll. fda is providing information and recommendations regarding the zoll lifevest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying "call for service: device has a problem that may require service. call zoll for service, message code 102." ideally, the lifevest monitors the patient's heart, delivering a "treatment shock" as needed to restore the patient's heartbeat to a normal rhythm. however, fda is aware that in certain cases the lifevest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. during normal operation, this fault prompts the lifevest to display "call for service: device has a problem that may require service. call zoll for service, message code 102" on the device screen. the "message code 102" alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call the manufacturer immediately. fda is aware of one patient death due to the lifevest's failure to deliver treatment as expected after message code 102 was displayed. according to the manufacturer, about 0.1% of the total devices distributed have displayed message code 102, which should only be remedied by immediate replacement of the device. the fda has provided recommendations for healthcare providers, patients and caregivers. for details, please visit the following fda website: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm592710.Htm https://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm592583.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 18 january 2018.

Device

LifeVest 4000 Wearable Cardioverter Defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
  • Manufacturer
    Zoll

Manufacturer

Zoll