Events

Retiro De Equipo (Recall) de Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier

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 Sunrise Medical HHG Inc. dba DeVilbiss Healthcare.

¿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
    59042
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2990-2011
  • Fecha de inicio del evento
    2011-03-11
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100885
  • 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
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Causa
    Some units were manufactured with a defective humidifier chamber o-ring. unit could leak, allowing water to escape during use, causing damage to furniture.
  • Acción
    The firm, DeVilbiss Healthcare, issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 11, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to verify their inventory of CPAPs with Heated Humidifiers and isolate any units that are included in the list; replace the humidifier chamber o-rings with the new ones provided; discard the original o-ring removed from the humidifier chamber; complete and return the URGENT: MEDICAL DEVICE CORRECTION Confirmation letter via mail to Quality Manager, DeVilbiss Healthcare LLC, 100 DeVilbiss Drive, Somerset, PA, 15501; affirm that all units have been corrected and that all end users have been sent replacement parts, when all of the CPAPs on the serial number list have been corrected, and return a copy of the sign serial number sheet as confirmation. If you have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800-388-1988 from 8:00AM-5:00PM EST.

Device

Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier
  • Modelo / Serial
    Model number DV5HH, serial number range from HH073341 to HH077139.  Model number DV51D-HH, serial number range from ID022837 to ID023117.  Model number DV53-HH, serial number range from JD004065 to JD004224.  Model number DV54D-HH, serial number range from HD023473 to HD024014.  Model number DV55D-HH, serial number range from KD005598 to KD005695.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution; USA (nationwide) including states of AL, AR, CA, FL, IL, IN, IA, KS, KY, MD, MA, MI, MS, NE, NJ, NY, OH, PA, WA, WV, and WI; and countries of Europe.
  • Descripción del producto
    DeVilbiss Model DV5x Series CPAP with Heated Humidifier || Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
  • Manufacturer
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare

Manufacturer

Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
  • Dirección del fabricante
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare, 100 DeVilbiss Drive, Somerset PA 15501-2125
  • Source
    USFDA