Events

Alerta De Seguridad para heartstart mrx monitor/defibrillators

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

¿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
    2013-06-20
  • Fecha de publicación del evento
    2013-06-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620a.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/defibrillators the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning certain models of heartstart mrx monitor/defibrillators [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5, m3536m6], manufactured by philips healthcare. the affected units include those manufactured by philips between february 2004 and may 2013, and with serial numbers between us00100100 to us00567299. a philips heartstart mrx monitor/defibrillator could deliver a non-synchronised cardioversion shock when the user rotates the therapy knob while simultaneously pressing the sync button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation. additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use. the manufacturer is providing work around instructions as an interim measure. a software update and device label revision will be supplied to users as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00622-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2013.

Device

heartstart mrx monitor/defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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