Events

Alerta De Seguridad para Monitor Arm AC 3000

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

¿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
    2013-11-29
  • Fecha de publicación del evento
    2013-11-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131129.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: draeger monitor arm ac 3000 medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning its adjustable monitor arm [model no.: ac3000; part no.: g92756 and g94499]. according to the manufacturer, the other part numbers are not affected. the manufacturer has discovered a case in which the monitor support bracket detached from the joint pin at the bottom of the height adjustable spring arm ac3000. the monitor support bracket fell down together with the monitor until it was only held by electrical cable connections. although no one was injured, a falling monitor support has the potential to cause personal injury. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. the manufacturer advises affected users to handle the monitor arm with care and to pay attention to any increasing free play between the pins and the monitor arm. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2013.

Device

Monitor Arm AC 3000
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Draeger Monitor Arm AC 3000
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH