Retiro De Equipo (Recall) de Device Recall CARESCAPE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems Information Technologies, 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
    77818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0202-2018
  • Fecha de inicio del evento
    2017-07-13
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Device does not produce a visual or audible impedance respiration apn alarm when an impedance respiration apnea event occurs.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any questions pertaining to this recall.

Device

  • Modelo / Serial
    Model No. 2042084-001. Serial No. SA314096842GA, SA314212130GA, SA313430730GA, SA313430743GA, SA313430731GA, SA313430735GA, SA313430771GA, SA313430795GA, SA313430801GA, SA313430806GA, SA313430813GA, SA313441307GA, SA313441311GA, SA313441399GA, SA313441414GA, SA313441474GA, SA314086697GA, SA313272250GA, SA313378480GA, SA313419589GA, SA313430691GA, SA313430697GA, SA313430700GA,  SA313430705GA, SA313430706GA, SA313430711GA, SA313430713GA,  SA313430715GA, SA313430723GA, SA313430724GA, SA313430751GA, SA313430752GA, SA313430753GA, SA313430755GA, SA313430757GA, SA313430759GA, SA313430761GA, SA313430762GA, SA313430763GA, SA313430764GA, SA313430766GA, SA313430767GA, SA313430777GA, SA313430779GA, SA313430780GA, SA313430781GA, SA313430783GA, SA313430784GA, SA313430789GA, SA313430790GA, SA313430792GA, SA313430793GA, SA313430794GA, SA313430796GA, SA313430797GA, SA313430798GA, SA313430799GA, SA313430802GA, SA313430804GA, SA313430805GA, SA313430807GA, SA313430808GA, SA313430809GA, SA313430812GA,SA313430815GA, 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
  • Descripción del producto
    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software || The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    GE Medical Systems Information Technologies, Inc., 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA