Events

Alerta De Seguridad para Precise RX Pediatric Flowmeter

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

¿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
    2016-07-25
  • Fecha de publicación del evento
    2016-07-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725b.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: invacare precise rx pediatric flowmeter health canada posted a medical device safety alert concerning invacare precise rx pediatric flowmeter [model numbers: ircpf16, ircpf16aw; lot numbers: 16bf017557, 16cf030112, 16cf030121, 16cf032024, 16cf040071, 16cf040083, 16df040094], manufactured by invacare corporation. the manufacturer has identified that the rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population, health impact specific to high oxygen saturation could result in systemic toxicity, potential lung vascular injury, or over extended period of time could cause blindness. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59460r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.

Device

Precise RX Pediatric Flowmeter
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Invacare Precise RX Pediatric Flowmeter
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation