Events

Alerta De Seguridad para HEARTSTART MRX DEFIBRILLATOR, Models M3535A, M3536A, M3536M4, M3536M5 and M3536M6. Anvisa Registry: 10216710136. Series Affected: http://portal.anvisa.gov.br/wps/wcm/connect/eb2d60004bcbbfc2b2d8fbbc0f9d5b29/Produtos+Afetados.pdf?MOD=AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PHILIPS LTDA.

¿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
  • ID del evento
    1149
  • Fecha
    2012-06-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Affected MRx devices may have the following behaviors (A, B and / or C): A. In DEA mode, the MRx presents difficulties in interpreting the ECG waveforms of the electrode pads and may incorrectly analyze the waveforms ( possibility of inadequate treatment) or unable to analyze them. B. In the manual mode, the user may have difficulty interpreting the ECG waveforms acquired by the electrode pads and determining if there is a need for treatment. In addition, the MRx can provide false alarms (such as EsV / min max, TAQUI-V, Asystole) or indicate an asymmetric rhythm even when the external paddles are not in contact with the patient. C. If the CPR meter is used, users may not get adequate ventilation feedback from the impedance.
  • Causa
    Ability to obtain an ecg signal from the external paddles and paddles to determine the need for affected treatment.
  • Acción
    1) Perform an Operational Test at the beginning of each shift or team change. If the problem has occurred, the device will fail after the Operational Test and alert the user by displaying a solid red X and beeping. If the device fails during the Operational Test, remove it from operation and contact your Philips service representative. 2) The affected units may remain in service as long as the following instructions are followed: • Perform Operational Tests at the beginning of each shift or team change. • Do not use DEA mode. • When performing manual defibrillation, use the Select Derivation Button to select the ECG lead signal (Derivations I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6) and display the signal of ECG shunts when deciding whether or not to apply the shock and apply the shock. • All users should be aware of these limitations. Philips recommends making a backup defibrillator available if possible. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/b63af2004bcbbf5db2cffbbc0f9d5b29/Carta+ao+Cliente.pdf?MOD=AJPERES

Device

HEARTSTART MRX DEFIBRILLATOR, Models M3535A, M3536A, M3536M4, M3536M5 and M3536M6. Anvisa Registr...

Manufacturer

PHILIPS LTDA
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA