Events

Alerta De Seguridad para m1783a and m5526a 12 pin sync cables

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

¿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
    2014-12-12
  • Fecha de publicación del evento
    2014-12-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141212.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 medical systems m1783a and m5526a 12 pin sync cables the australian therapeutic goods administration (tga), has issued a medical device safety alert concerning its heartstart xl (m1783a and m5526a) 12 pin sync cables, manufactured by philips medical systems. according to the tga, the following problems were found during internal testing:-if electrical fast transits (eft) noise is injected into the monitor/defibrillator via ac mains power, and the monitor/defibrillator is connected to and receiving ecg signals from an auxiliary bedside monitor with an m1783a/m5526a 12 pin sync cable (8/24 feet) via the monitor’s ecg out port, then:- issue 1: when using a sync cable with the heartstart mrx or heartstart xl, eft noise can be mistaken as an r-wave. if this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to eft noise instead of the patient’s actual r-wave. issue 2: when using a sync cable with the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. a power cycle is required to resume ecg monitoring, however, fixed mode pacing is not impacted by this issue. the manufacturer will contact affected customers to arrange for replacement of new sync cable. for details, please refer to the following link: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2014-rn-01291-1 according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2014.

Device

m1783a and m5526a 12 pin sync cables
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Medical Systems M1783A and M5526A 12 pin Sync Cables
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH