Events

Alerta De Seguridad para Physiological monitoring system, intensive treatment and short duration: 0998-00-0170-0042A, (59) Model 0998-00-0170-0042F, (60) Model 0998-00-0170-0044A, (61) Model 0998-00 -0170-0044P, (62) Model 0998-00-0170-0045A, (63) Model 0998-00-0170-0045F, (64) Model 0998-00-0170-0046A, (65) Model 0998-00-0170 -0046F, (66) Model 0998-00-0170-0046G, (67) Model 0998-00-0170-0046P, (68) Model 0998-00-0170-0046T, (69) Model 0998-00-0170-0048A , (70) Model 0998-00-0170-0048P, (71) Model 0998-00-0170-0050A, (72) Model 0998-00-0170-0054A, (73) Model 0998-00-0170-0055A, ( 74) Model 0998-00-0170-0061A, (75) Model 0998-00-0170-0062A, (76) Model 0998-00-0170-0064A, (77) Model 0998-00-0170-3006A, (78) Model 0998-00-0170-3006T, (79) Model 0998-00-0170-3013A, (80) Model 0998-00-0170-3014A, (81) Model 0998-00-0170-3014F, (82) Model 0998 -00-0170-3014G, (83) Model 0998-00-0170-3014T, (84) Model 0998-00-0170-3015A, (85) Model 0998-00-0170-3016A, (86) Model 0998-00 -0170-3016G, (87) M odelo 0998-00-0170-3038A, (88) Model 0998-00-0170-3038T, (89) Model 0998-00-0170-3040A, (90) Model 0998-00-0170-3040P, (91) Model 0998 -00-0170-3045A, (92) Model 0998-00-0170-3046A, (93) Model 0998-00-0170-3046F, (94) Model 0998-00-0170-3046G, (95) Model 0998-00 -0170-3046T, (96) Model 0998-00-0170-3047A, (97) Model 0998-00-0170-3048A, (98) Model 0998-00-0170-3048G, (99) Model 0998-00-0170 -3048T. Vital Signs Monitors Passaport 2: (1) Model 0998-00-0170-0001A, (2) Model 0998-00-0170-0001F, (3) Model 0998-00-0170-0002A, (4) Model 0998-00 -0170-0002D, (5) Model 0998-00-0170-0002F, (6) Model 0998-00-0170-0002G, (7) Model 0998-00-0170-0002P, (8) Model 0998-00-0170 -0002T, (9) Model 0998-00-0170-0003A, (10) Model 0998-00-0170-0004A, (11) Model 0998-00-0170-0004G, (12) Model 0998-00-0170-0005A , (13) Model 0998-00-0170-0006A, (14) Model 0998-00-0170-0006D, (15) Model 0998-00-0170-0006G, (16) Model 0998-00-0170-0007A, ( 17) Model 0998-00-0170-0008A, (18) Model 0998-00-0170-0009A, (19) Model 0998-00-0170-0009F, (20) Model 0998-00-0170-0010A, (21) Model 0998-00-0170-0010F, (22) Model 0998-00-0170-0010G, (23) Model 0998-00-0170-0011A, (24) Model 0998-00-0170-0012A, (25) Model 0998 -00-0170-0012G, (26) Model 0998-00-0170-0012P, (27) Model 0998-00-0170-0013A, (28) Model 0998-00-0170-0013D, (29) Model 0998-00 -0170-0013F, (30) Model 0998-00-0170-0013T, (31) Mod link 0998-00-0170-0014A, (32) Model 0998-00-0170-0014F, (33) Model 0998-00-0170-0014G, (34) Model 0998-00-0170-0014T, (35) Model 0998 -00-0170-0015A, (36) Model 0998-00-0170-0016A, (37) Model 0998-00-0170-0017A, (38) Model 0998-00-0170-0021A, (39) Model 0998-00 -0170-0022A, (40) Model 0998-00-0170-0023A, (41) Model 0998-00-0170-0029A, (42) Model 0998-00-0170-0031A, (43) Model 0998-00-0170 -0032A, (44) Model 0998-00-0170-0034A, (45) Model 0998-00-0170-0034F, (46) Model 0998-00-0170-0034P, (47) Model 0998-00-0170-0036A , (48) Model 0998-00-0170-0036P, (49) Model 0998-00-0170-0037A, (50) Model 0998-00-0170-0038A, (51) Model 0998-00-0170-0038F, ( 52) Model 0998-00-0170-0038G, (53) Model 0998-00-0170-0038T, (54) Model 0998-00-0170-0039A, (55) Model 0998-00-0170-0040A, (56) Model 0998-00-0170-0040P, (57) Model 0998-00-0170-0041A, (58) Model

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Datascope Corp Patient Monitoring Div.

¿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
    246
  • Fecha
    2001-09-21
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The power supply to the monitors listed above may fail when the printer / recorder is activated, thus causing a temporary loss in the alarm activations. datascope states that for most patients, the risk associated with power failure may be insignificant; however, the risk is increased in patients with unstable medical conditions. if a monitor restarts in the absence of a medical staff, the patient may be left unmonitored for up to 35 seconds and all temporary alarm activations will be changed to the last saved settings without any indication to the clinician. the manufacturer initiated the correction by letter dated may 25, 2001.
  • Acción
    Verify receipt of the correction notice dated May 25, 2001 from Datascope. ECRI recommends that you identify and isolate the entire affected product in the inventory. A Datascope representative will replace the current power supply at no charge. At the end of the job, you will be asked to sign a service report to check the degree of job satisfaction. Meanwhile, ECRI suggests that the record alarm function be set to "off" to prevent automatic printing if the alarm sounds. Let the impression be manually activated by a clinician in the patient's presence so that the patient is observed if the monitor restarts. For more information, contact your local representative or the telephone number (201) 995-8237 (outside the United States).

Device

Physiological monitoring system, intensive treatment and short duration: 0998-00-0170-0042A, (59)...

Manufacturer

Datascope Corp Patient Monitoring Div
  • Source
    ANVSANVISA