Events

Retiro De Equipo (Recall) de QuietCare

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 Intel-GE Care Innovations 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
    61834
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1703-2012
  • Fecha de inicio del evento
    2011-08-01
  • Fecha de publicación del evento
    2012-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109203
  • 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
    System, environmental control, powered - Product Code IQA
  • Causa
    On 7/29/11, the quietcare production system experienced a partial outage from about 15:00 hours until 22:30. during the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. failure to generate alerts in a timely manner could result in a.
  • Acción
    Intel-GE Care Innovations sent an "URGENT FIELD NOTIFICATION" e-mail dated August 12, 2011 to all affected customers. The notification identifies the product and problem. No action is required by the customers. Contact Customer Service at (866) 772-8243 for questions regarding this notice.

Device

QuietCare
  • Modelo / Serial
    Affected Hardware Serial Numbers: 020685, 020267, 021542, 018880, 021585, 024179, 022003, 020232, 020272, 024148, 024252, 017044, 017648, 023385, 018651, 024376, 023988, 018567, 017151, 018460, 026701, 021130, 021366, 017735, 019229, 026371, 026317, 018010, 026334, 017471, 019952, 026293, 019476, 026292, 017089, 019953, 026335, 018630, 026439, 026378, 026260, 026239, 022050, 019477, 018379, 024346, 018224, 023936, 020421, 022129, 022216, 018543, 026760, 024270, 021649, 021918, 023465, 023531, 020716, 018962,  020718.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-USA (nationwide) including the states of Arizona, California, Connecticut, Idaho, Illinois, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Utah.
  • Descripción del producto
    Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.
  • Manufacturer
    Intel-GE Care Innovations LLC

Manufacturer

Intel-GE Care Innovations LLC
  • Dirección del fabricante
    Intel-GE Care Innovations LLC, 3721 Douglas Blvd Ste 100, Roseville CA 95661-4243
  • Source
    USFDA