Events

Alerta De Seguridad para mrx lithium ion 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
    2014-02-20
  • Fecha de publicación del evento
    2014-02-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220.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 mrx lithium ion batteries medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning heartstart mrx lithium ion batteries with battery model number m3538a revision j and the affected battery serial numbers are: 11327-0019-p, 11315-0023-p, 11315-0027-p, 11315-0031-p, 11315-0032-p, 11315-0033-p, 11315-0036-p, 11315-0109-p, 11315-0214-p, 11315-0219-p, 11315-0391-p, 11322-0084-p, 11322-0088-p, 11327-0043-p, 11327-0044-p; or within range 11335-xxxx-p to 13214-xxxx-p according to the manufacturer, the philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from radio frequency (rf) energy sources. examples of equipment that can cause electromagnetic interference are medical devices, cellular products, information technology equipment and radio/television transmissions. the manufacturer provides users with the following information and advice: the condition can be avoided by operating the device on ac or external dc power or by the following actions when operating on battery power: 1) before placing a heartstart mrx into use, insert a fully-charged battery with five solid green lights on the battery fuel gauge when the fuel gauge button is pressed; 2) if the device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. if there are no lights, insert a fully-charged mrx battery fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. the manufacturer advises users to see the heartstart mrx instructions for use for the minimum recommended separation distance between rf communications equipment and the heartstart mrx. furthermore, the manufacturer will replace affected batteries. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

mrx lithium ion batteries
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx Lithium Ion batteries
  • Manufacturer
    Philips Healthcare

Manufacturer

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