Events

Alerte De Sécurité sur 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

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 Datascope Corp Patient Monitoring Div.

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
    246
  • Date
    2001-09-21
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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