Events

Alerta De Seguridad para automated external defibrillator LIFEPAK 1000

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

¿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
    2017-01-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    http://www.info.gov.hk/gia/general/201701/20/P2017012001021.htm?fontSize=1
  • 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
    Press release
  • Causa
     
    safety alert on automated external defibrillator lifepak 1000
    *************************************************************
         the department of health (dh) today (january 20) drew the public's attention to a safety alert concerning the lifepak 1000 defibrillator manufactured by physio-control as this automated external defibrillator would reportedly shut down unexpectedly during patient treatment.

         the dh, through its routine surveillance on medical device safety alerts, noticed the above alert issued by the food and drug administration of the united states.
     
         according to the alert, the manufacturer has received 34 reports that the device has shut down unexpectedly during patient treatment due to an intermittent connection between the battery and device electrical contacts.

         according to the manufacturer, this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for a long period of time.

         the alert has indicated that a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. the manufacturer is aware of eight adverse events related to this issue.

         this issue can potentially affect any lifepak 1000 device. however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible.

         the dh's enquiries with the manufacturer’s branch office in singapore revealed that 653 units of the potentially-affected device had been distributed in hong kong, including local distributors, medical organisations, estate management agencies, recreational clubs, schools and other venues. 

         "so far, the dh has not received any reports of adverse incidents related to the affected device in hong kong," a spokesman for the dh said.

         "the dh has also informed public and private hospitals and relevant medical associations about the alert and will continue to liaise with the manufacturer on the follow-up actions," the spokesman said.

         members of the public who are in possession of the affected device are advised to immediately remove and reinstall the battery from their devices and to implement a weekly schedule of battery removal and reinstallation for all lifepak 1000 devices. this action will clean the contacts of oxidation and will prevent the issue from occurring.

         according to the manufacturer, if the device powers off unexpectedly, either during inspection or during patient treatment, the battery should be immediately removed and reinstalled to restore power to the device. if the power is not restored, replace the battery with a spare battery and contact the supplier to arrange for servicing of the device.
     
    ends/friday, january 20, 2017
    issued at hkt 20:00
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Device

automated external defibrillator LIFEPAK 1000
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety alert on automated external defibrillator LIFEPAK 1000
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH