Events

Retiro De Equipo (Recall) de Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty 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
    RC-2017-RN-01429-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01429-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic has identified specific units of lithium ion batteries which are used in puritan bennett 980 ventilators, following reports that the batteries may not fully charge after installation. the scope of this notice includes batteries that were manufactured between december 2013 and may 2017, with serial numbers begin with 1201xxxxxx through 1712xxxxxxa functional battery installed in the pb980 ventilator automatically recharges when the battery depletes and the ventilator is connected to ac power. in the case of a battery with incorrect firmware, it may fail to fully charge. this situation does not impact the ventilator’s operation when it is connected to ac power. however, if the ventilator is operated on battery power alone, this situation could limit the amount of time the ventilator is operational.
  • Acción
    Notify all care environments in which the PB980 ventilators are used about this notification. If PB980 ventilators have been distributed to other persons or facilities, promptly forward a copy of this letter to them. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Medtronic service engineers will inspect batteries in the field during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. The PB980 ventilator may continue to be used as described in the Operator’s Manual.

Device

Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators
  • Modelo / Serial
    Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 VentilatorsProduct Code: 10086042Serial Numbers beginning with 1201xxxxx through 1712xxxxxxARTG Number: 221452
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA