Events

Retiro De Equipo (Recall) de POWER PRO IT AMBULANCE COT

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

¿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
    105570
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-23
  • País del evento
    Canada
  • 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
    A few service reports alleged that "smoke" was coming from the foot end of the cot. this reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. in addition to the alleged smoking one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed retract and then a few moments later it began to smoke.

Device

POWER PRO IT AMBULANCE COT
  • Modelo / Serial
    Model Catalog: 6516000000 (Lot serial: 150840805); Model Catalog: 6500002014 (Lot serial: N/A); Model Catalog: 6506000000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    POWER PRO IT AMBULANCE COT;CONTROL BOARD FOR POWER PRO AMBULANCE COT;POWER PRO AMBULANCE COT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC