Events

Alerta De Seguridad para HeartStart MRx Monitor/Defibrillator with Q-CPR

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

¿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
    2015-09-01
  • Fecha de publicación del evento
    2015-09-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150901a.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: philips heartstart mrx monitor/defibrillator with q-cpr medical device manufacturer, philips, has issued a medical device safety alert concerning its heartstart mrx monitor/defibrillator with q-cpr. the affected devices are identified as follows:-  units affected: all q-cpr meter and cpr sensor;  model number: 453564145481, 453564257691 and m4761a during internal review, the manufacturer identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. in addition, instructions did not inform the users that properly performed cpr can result in injuries to the patient. the manufacturer has updated the heartstart mrx’s instructions for use associated with q-cpr sensor via an addendum. the addendum has instructions on application of the disposable adhesive pads, which are used with the q-cpr meter, including a diagram which illustrates proper placement and orientation of this pad. in addition, the addendum includes general information on the types of injuries, which may occur during cpr. according to the local supplier, the q-cpr meter and cpr sensor are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 september 2015.

Device

HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH