Events

Retiro De Equipo (Recall) de ProBP 2400 Digital Blood Pressure DeviceSerial

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Welch Allyn Australia Pty Limited.

¿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-00922-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-27
  • 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-00922-1
  • 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
    Welch allyn has been made aware of a product quality issue which could potentially affect the probp 2400 digital blood pressure devices manufactured by microlife and distributed by welch allyn. as a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery.The over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.This issue may lead to patient and/or caregiver burns as result of skin contact with melted plastic and/or delays in treatment.
  • Acción
    The affected devices within the Serial Numbers specified in the customer letter are being recalled and will be replaced with new devices at no cost to affected customers.

Device

ProBP 2400 Digital Blood Pressure DeviceSerial
  • Modelo / Serial
    ProBP 2400 Digital Blood Pressure DeviceSerial Number ranges:(21)07150001 – (21)07150620 (21)12150001 – (21)12150500 Please note: (21) is NOT part of the Serial Number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the Serial Number on any GUDI compliant label.ARTG Number: 232592
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited