Events

Retiro De Equipo (Recall) de Device Recall V60 Ventilator

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 Respironics California 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
    65376
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1537-2013
  • Fecha de inicio del evento
    2013-06-04
  • Fecha de publicación del evento
    2013-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118739
  • 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, continuous, minimal ventilatory support,facility use - Product Code MNT
  • Causa
    Respironics california, inc. has initiated a recall on the v60 ventilator because of an issue with the software on the v60 power management board assembly. if a component fails on the power management board assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
  • Acción
    The firm, Philips Healthcare, sent a "MEDICAL DEVICE CORRECTION" letter dated June 3, 2013 to all customers who received the V60 Ventilators. The letter describes the product, problem identified and the actions to be taken. The customers were informed that the V60 ventilator may continue to be used in accordance with its directions for use, pending the completion of the update. In addition, the customers were instructed to refer to their manual for additional information on warnings. A Philips Field Service Engineer, Approved Sevice Provider or Distributor will be contacting the customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013. If you need any further information or support concerning this issue, contact your local Philips Respironics representative at (800) 722-9377.

Device

Device Recall V60 Ventilator
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.
  • Descripción del producto
    Respironics V60 Ventilator, Model #V60 || Respironics Material P/N (Philips 12 Digit P/N): || 85008 (85008) || 1053613 (989805628251) || 1053614 (989805612101) || 1053615 (989805613391) || 1053616 (989805613661) || 1053617 (989805611761) || 1053618 (n/a) || R1053618 (n/a) || 1076709 (n/a) || 1076715 (989805627411) || 1076716 (989805627431) || 1076717 (989805627441) || DU1053617 (989805616411) || U1053614 (989805636441) || U1053617 (989805636631) || Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. || The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Dirección del fabricante
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA