Events

Retiro De Equipo (Recall) de Manual pulmonary respirator (RPM, Manual insufflator)

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Unomedical France.

¿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
  • Fecha
    2009-10-16
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dispositif-medical-respirateur-pulmonaire-manuel-rpm-insufflateur-manuel-unomedical
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On 15/10/2009, the company Unomedical France has withdrawn from the market the batches of the references cited in the appendix (16/10/2009) (12 ko) of the recall letter of the medical device called: Manual pulmonary respirator (RPM, Manual insufflator ), manufactured by Unomedical (Mexico) following the discovery of a manufacturing defect in the production of this device. Indeed, on some manual pulmonary breathing apparatus (manual insufflator), the duckbill valve and the retaining ring inside the patient valve housing could dislodge and fall into the balloon or body of the patient. manual resuscitator (RPM). If this occurs, the Manual Resuscitator (RPM) may lose its ability to produce the positive pressure needed to ventilate the patient, which may compromise ventilation to the patient and potentially have serious consequences for the patient's condition. of the patient's health. The company Unomedical France has directly notified the recipients of the incriminated lots with the message attached (16/10/2009) (71 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities have been informed of this measure by manufacturer.

Device

Manual pulmonary respirator (RPM, Manual insufflator)

Manufacturer

Unomedical France