Events

Retiro De Equipo (Recall) de Device Recall AliMed IQ Cupid Pull Cord Alarm

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 AliMed Corporation.

¿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
    54783
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1407-2010
  • Fecha de inicio del evento
    2010-02-12
  • Fecha de publicación del evento
    2010-04-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89165
  • 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
    Alimed became aware of issue via internal receiving inspection activities on 1/20/09. firm states that subsequent to this observation, customer dissatisfaction inquiry #100192 was generated on 1/22/10. a single unit was received back by alimed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. failure of the alarm.
  • Acción
    Letter sent to customers stating that some units may have been subjected to excessive heat during the manufacturing process causing internal distortion to a key alarm component. The letter also request that the Health Care professional review records and notify all users to whom the product may have been issued and if any product has been issued outside of their facility, to forward this correspondence to them. Firm has enclosed a form for return of the product and issuance of a new product. For questions, please contact the firm using the information provided in the letter.

Device

Device Recall AliMed IQ Cupid Pull Cord Alarm
  • Modelo / Serial
    Product Code KMI, Models #710436
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    All product was distributed domestically with the exception of one unit sold in Canada. AliMed sells and distributes this product to medical health professionals and distributors as well as directly to end users
  • Descripción del producto
    Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.
  • Manufacturer
    AliMed Corporation

Manufacturer

AliMed Corporation
  • Dirección del fabricante
    AliMed Corporation, 297 High St, Dedham MA 02026
  • Source
    USFDA