Alerte De Sécurité sur 1) ELECTROMYOGRAPHS; (2) ELETROENCEFALOGRAFOS; (3) UNITS OF EVOCATED POTENTIAL; (4) PHYSIOLOGICAL MONITORS

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 N/A.

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
    127
  • Date
    2000-09-22
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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).
  • Action
    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