Retiro De Equipo (Recall) de ROOMER S

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HUMAN CARE CANADA INC..

¿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
    45051
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-11-05
  • País del evento
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Two identified problems that human care has decided to address. the first problem is related to a fixation screw on the telescopic hanger bar used on recalled device. this screw is located inside the unit hence not visible from the outside. a minor number of units have been detected where the level of loctite applied to the screw during manufacturing has been insufficient. this can cause the telescopic hanger bar to lose from its position and in a worst case fall out of its position. the second problem is related to the swivel hooks on the telescopic hanger bar. it has come to human cares attention that if the telescopic hanger bar is incorrectly used namely the swivel hooks on the hanger bar is faulty positioned before a patient transfer this can cause the sling out of its position which can result in a hazard to the user. it is important that the user manual is followed and that the hanger bar and its hooks are adjusted and positioned correctly prior to any patient transfer.

Device

  • Modelo / Serial
    Model Catalog: 55300-XX (Lot serial: 32578510009); Model Catalog: 55300-XX (Lot serial: 32578510006); Model Catalog: 55220-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55210-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55200-XX (Lot serial: >10 lot numbers contact mfg)
  • Descripción del producto
    ROOMER S
  • Manufacturer

Manufacturer