Events

Retiro De Equipo (Recall) de BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation

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 Del Mar Reynolds Medical, Ltd..

¿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
    66721
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0352-2014
  • Fecha de inicio del evento
    2013-10-17
  • Fecha de publicación del evento
    2013-11-20
  • 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=123126
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    Spacelabs healthcare ltd. of united kingdom recalls , and service kits, part number 050-0659-00 and 050-0901-00. the bag to-vent switch in cas i/ii absorbers may fail due to loose fastening hardware in an absorber.
  • Acción
    Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated November 1, 2013, to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record via e-mail on November 6, 2013. The letter informed customers of a potential defect in CAS I/II Absorber products employed in the Spacelabs Healthcare BleaseSirius Anesthesia Workstation, and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag-to-Vent switch in CAS I/II Absorbers may fail. In the worst case, this would result in a large leak from the absorber circuit and could impede the ability to provide ventilation. Customers were instructed to immediately advise their staff of the problem. Customers with questions were instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025.

Device

BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation
  • Modelo / Serial
    SERIAL NUMBERS IN THE US:  ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135.   SERIAL NUMBERS INTERNATIONAL:  ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
  • Descripción del producto
    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. || BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • Dirección del fabricante
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA