Alerta De Seguridad para 1) ELECTROMYOGRAPHS; (2) ELETROENCEFALOGRAFOS; (3) UNITS OF EVOCATED POTENTIAL; (4) PHYSIOLOGICAL MONITORS

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

¿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
    127
  • Fecha
    2000-09-22
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
  • Acción
    TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.

Manufacturer

N/A
  • Source
    ANVSANVISA