Events

Retiro De Equipo (Recall) de 3600 MONOPLACE HYPERBARIC CHAMBERS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SECHRIST INDUSTRIES 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
    104024
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-10-26
  • 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
    Three issues were identified with these units. these include locking up of the display / control panel when the chamber is first turned on. this prevents initial operation of the chamber. the condition can be cleared by temporarily unplugging the chamber from the wall power source and disconnecting the battery back-up. this resets the control panel. once this is performed the chamber can continue to be used. the second is the chamber going into the safe state condition during treatment when the operator has touched or adjusted the controls. after completion of decompression in the safe state mode the treatment can be resumed. following the safe state initiation an inspection of the chamber does not indicate any anomaly that would result in the initiation of a safe state condition. the third issue involves the chamber automatically going into a safe state condition during treatment on its own without any operator action. following the safe state initiation an inspection of the chamber fails to indicate any anomaly that would result in the initiation of a safe state condition. no reports of injuries or death reported.

Device

3600 MONOPLACE HYPERBARIC CHAMBERS
  • Modelo / Serial
    Model Catalog: 3600ER (Lot serial: 360029); Model Catalog: 3600E (Lot serial: 360032); Model Catalog: 3600E (Lot serial: 360029); Model Catalog: 3600ER (Lot serial: 360032)
  • Descripción del producto
    Monoplace 3600 Hyperbaric Chambers
  • Manufacturer
    SECHRIST INDUSTRIES INC.

Manufacturer

SECHRIST INDUSTRIES INC.