Events

Alerte De Sécurité sur Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III; Affected models: MRx and XL +; Affected series / lots: US00119303; US00119304; US00121905; US00121913; US00122596; US00122597; US00122710; US00122711; US00122712; US00122779; US00122780; US00122781; US00122782; US00122783; US00607333; US00607334; US00607335; US00607336; US00607337; US00607338; US00607339 and US00607340.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1860
  • Date
    2016-04-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Philips will replace all affected sync cables with a new cable for free. A Philips Healthcare representative will contact customers with the affected devices to arrange replacement. If you find it difficult to follow the instructions contained in this release, please contact our Philips Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action proving the accomplishment of exchange, as planned.
  • Cause
    When a philips monitor / defibrillator is receiving an ecg signal from an auxiliary bed monitor via sync cable, if the monitor / defibrillator is subject to interference from efts while connected to ac power, the following may occur: • in heartstart mrx and heartstart xl, eft noise can be misinterpreted as an r-wave. • in the heartstart xl +, eft noise can deactivate ecg monitoring and possibly stop the stimulus in demand mode *. * note: it is contrary to the xl + instructions for use (ifu) to perform the stimulus in demand mode while using the sync cable to deliver the ecg signal from a bed monitor. the xl + ifu includes the following warning: when stimulating in demand mode, the patient's ecg cable must be connected directly to the heartstart xl +. "if you follow this warning, this problem can not occur on xl +.
  • Action
    Field Action Code: FCO86100165. Field Correction by Replacing the Affected Sync Cables ///// Recommendations to Users and Patients: Before receiving a replacement sync cable, you can continue to use the affected sync cables provided they are used only to connect the plug ECG output on the monitor / defibrillator to the (input) port of the ECG on a bed monitor. The problems described do not impact this application of the sync cable. The affected sync cables should not be used to connect the ECG output plug of a bed monitor to the ECG (input) port on the monitor / defibrillator.

Device

Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III...

Manufacturer

Philips Medical Systems Ltda.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA