Events

Retiro De Equipo (Recall) de Device Recall Ultraview SL Capnography Module

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 Spacelabs Healthcare, Llc.

¿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
    58811
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2573-2011
  • Fecha de inicio del evento
    2011-05-12
  • Fecha de publicación del evento
    2011-06-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100345
  • 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
    Capnography module, model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. this reset clears the ram and the module returns to default settings.
  • Acción
    Spacelabs Medical sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to "ON". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption. A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost to the customer. For questions about this corrective action program, call Spacelabs Medical at 1-800-522-7025, Select 2 for Technical Support. For outside the US, customers can call 1-425-657-7200, x5089.

Device

Device Recall Ultraview SL Capnography Module
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PALESTINE, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, REPUBLIC OF CHINA, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • Descripción del producto
    The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. || Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. || Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. || The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA