Events

Retiro De Equipo (Recall) de HEARTSTART XL+

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS 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
    59988
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Through internal testing and customer complaint investigations the following xl+ software and hardware issues have been identified: software: 1. the xl+ may fail to complete the power on sequence and continuously reboot. 2.The xl+ may either fail to power up or may shut down unexpectedly. 3. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. 4. the xl+ may fail to generate verbal prompts in aed mode. hardware: a. the xl+ may have been manufactured with a speaker that may fail. b. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. c. the xl+ exceeds the allowable radiated emissions level for class b cispr11. d. the xl+ ecg signal from leads could be lost and unrecoverable. e. the xl+ spo2 signal may lose communication and cause the device to reboot. f. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

Device

HEARTSTART XL+
  • Modelo / Serial
    Model Catalog: 861290 (Lot serial: >10 contact mfg.)
  • Descripción del producto
    HEARTSTART XL+
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC