Events

Retiro De Equipo (Recall) de Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00773-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00773-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Philips healthcare has received a number of complaints about visible mould on gel-e donut and squishon 2 gel-filled products. the mould manifests as small black markings on the outer surface of the gel-e donut and squishon pad, which are visible through the transparent outer packaging. the mould detected on the product has been cladosporium and penicillium fungi, which are commonly found moulds. nicu and picu patients are much more sensitive to moulds and there is potential for the mould to be transferred to these environments once the outer pack is opened.
  • Acción
    Users are advised to review their entire inventory of Gel-E Donut and Squishon 2 products and inspect each product for signs of visible mold. Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold. Dispose of any product containing mold per facility’s environmental guidelines and return unaffected product to their inventory. Customers are also referred to the Instructions for Use, in particular: Wipe all Gel product surfaces with an antibacterial agent and cover the Gel product with a disposable cover or soft cloth before patient use. This action has been closed-out on 17/08/2016.

Device

Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)
  • Modelo / Serial
    Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)Part numbers: 92025-A, 92025-B, 92025-C (Gel-E Donut) and 91033-2 (Squishon 2)ARTG number: 200647
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA