Events

Alerta De Seguridad para heartstart xl defibrillator/monitor with m3516a batteries

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

¿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
    2013-08-16
  • Fecha de publicación del evento
    2013-08-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816b.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: philips heartstart xl defibrillator/monitor with m3516a batteries the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning heartstart xl defibrillator/monitor with m3516a batteries of lot number with ‘lk’ prefix manufactured by philips healthcare. theaccording to the mhra, defibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from six months to three months. this applies to new batteries with the lot number prefix ‘lk’. the mhra clarifies that philips heartstart xl batteries with lot code prefixes ‘p’, ‘r’, and ‘pcs’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use). these batteries are still supported with relevant instructions for use and labelling. philips is supplying an addendum (see appendix of the alert) with battery orders and heartstart xl monitor/defibrillator orders stating the changes to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6). the mhra provides the following advice to the affected users: ensure all relevant staff are aware of the changes. ensure that the addendum is attached to the instructions for use and service manuals accordingly. be aware that this addendum supersedes any previous guidance given by philips regarding battery life and capacity test frequency. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con305480 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

heartstart xl defibrillator/monitor with m3516a batteries
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart XL defibrillator/monitor with M3516A batteries
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH