Events

Retiro De Equipo (Recall) de NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TRUDELL MEDICAL MARKETING LIMITED.

¿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
    54500
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-21
  • 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
    Vapotherm has received a small number of complaints involving a defect in the disposable patient circuit that allows water to leak into the center gas lumen that is beyond what would be attributed to normal condensation. recall has been issued to raise awareness of this issue and to remind users to follow the instructions for use recommendation that the cannula be connected to the patient only after the set temperature is reached.

Device

NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW
  • Modelo / Serial
    Model Catalog: PF-NODPC-LOW (Lot serial: LFN1404008); Model Catalog: PF-NODPC-LOW (Lot serial: LFN1405011); Model Catalog: PF-E-DPC-LOW (Lot serial: LFE1403002); Model Catalog: PF-DPC-HIGH (Lot serial: >100 numbers contact mfg); Model Catalog: PF-DPC-LOW (Lot serial: >100 numbers contact mfg)
  • Descripción del producto
    NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED