Events

Alerta De Seguridad para P300 and C300 Ceiling Hoist

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

¿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
    2015-10-02
  • Fecha de publicación del evento
    2015-10-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151002d.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: prism medical p300 and c300 ceiling hoist the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning p300 and c300 ceiling hoists, manufactured by prism medical. the affected model and serial numbers are shown below: lifter p300: models: 303050, 303051; serial: p303470 – 479, p304158/164/171/172, p304536 – 539, p304866/867, p305116/118, p305125 – 127, p305130/134/135 lifter c300: models: 330050, 330053; serial: c303221/224/225, cq303107 – 116 the manufacturer has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents, the manufacturer has discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur at the same time, there is a risk for the person being supported by the lift to drop unexpectedly. according to the safety alert, the patients involved in the 3 incidents were not seriously injured and did not require medical attention. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00967-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.

Device

P300 and C300 Ceiling Hoist
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Prism Medical P300 and C300 Ceiling Hoist
  • Manufacturer
    Prism Medical

Manufacturer

Prism Medical
  • Source
    DH