Events

Retiro De Equipo (Recall) de Device Recall Stanley BedCheck 90Day LT Bed Sensormat, With 5.5 Ft. Cord, Model 74001

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 Stanley Security Solutions, 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
    57987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1859-2011
  • Fecha de inicio del evento
    2009-11-25
  • Fecha de publicación del evento
    2011-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97932
  • 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, bed patient - Product Code KMI
  • Causa
    The cord could come loose from the mat potentially causing a short to the internal wiring.
  • Acción
    The firm, Stanley Healthcare Solutions, issued an "Important Technical Bulletin" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a "Compliance Notice" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to obtain a return authorization number and take immediate action to return the units to the firms location in Lincoln, Nebraska. The Compliance Notice informed the customers who had not sent in their units to promptly read the notice and take the necessary steps to respond appropriately for their facility. Additionally, the customers were instructed to complete and return the Bed Check Sensormat Return Form and page 2 of the "Compliance Notice" via at 402-475-4281 or mail to: Compliance Engineer, Stanley Security Solutions, Inc., 1550 N. 20th Circle, Lincoln, NE 68503. Follow-up phone calls to nonresponders were made using a phone script. A "Second Notice Compliance Notice" dated October 20, 2010 was issued via certified mail to customers asking for immediate response to the previous communication. In addition, a third notice dated October 28, 2010 which was also flagged as "Second Notice" was again used asking for a response from the customers. If you have any questions regarding the notice or any action that may need to be taken by you, please contact Quality Manager at 1-800-824-2996 extension 3419 or Compliance Officers at 402-742-9414 or 402-742-9425.

Device

Device Recall Stanley BedCheck 90Day LT Bed Sensormat, With 5.5 Ft. Cord, Model 74001
  • Modelo / Serial
    Lot numbers A0809, B0809, A0409, B0409, A0309, and B0309.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and the country of Canada.
  • Descripción del producto
    Stanley Bed-Check 90-Day LT Bed Sensormat, With 5.5 Ft. Cord, Model 74001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. || For use in reducing patient falls.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Dirección del fabricante
    Stanley Security Solutions, Inc., 1550 N 20th Cir, Lincoln NE 68503-1101
  • Empresa matriz del fabricante (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA