Events

Alerta De Seguridad para Puritan Bennett 840 Ventilator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Covidien.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-06-10
  • Fecha de publicación del evento
    2014-06-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140609.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: covidien puritan bennett 840 ventilator the australia therapeutic goods administration (tga) posted a medical device safety alert concerning puritan bennett 840 ventilator manufactured by covidien. the affected ventilator serial numbers are 3510102854, 3510102868, 3510102839, 3510102853, 3510102849, 3510102848 and 3510102852, and the serial numbers of the affected power supply units are 39302, 40221, 40355, 40465, 40324, 40327 and 40450. the manufacturer has received customer reports of the loss of graphical user interface (gui) display information while the ventilator continues to provide breath support. customer reports describe the gui display screens (both upper and lower) becoming blank during patient use. this event interferes with the clinician's ability to view and/or change ventilator setting or clinician-set patient alarm parameters. loss of gui display due to a power supply unit (psu) failure is demonstrated by the ventilator entering a “gui inop” state i.E. if the breath delivery unit (bdu) loses communication with the gui, the bdu recognises this and enters a “gui inop” state. it initiates the appropriate alarm consisting of a visible alarm indicated by the illumination of the “gui inop” red light on the bdu and a high-priority audible alarm. the source of the psu voltage loss is a specific circuit responsible solely for the gui central processing unit voltages. a representative from the manufacturer will perform an inspection of affected ventilator(s) to determine if it has the affected component and if so, will replace the psu immediately. if users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability i.E. confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring parameters (e.G., oxygen saturation, heart rate, blood pressure, etc). also, the manufacturer advises users to promptly transfer the patient to an alternate ventilator in a manner consistent with the institutional protocol and remove the affected ventilator from use until it has been serviced. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00618-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 june 2014.

Device

Puritan Bennett 840 Ventilator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Covidien Puritan Bennett 840 Ventilator
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH