Events

Alerta De Seguridad para Monnal T50 Technical Name: Ventilator Pressure and Volume ANVISA Registration Number: 80204410020 Hazard Class: III Model Affected: T 50 Serial Numbers Affected: MT50-06225; MT50-06226; MT50-06223; MT50-06232; MT50-06237; MT50-06224; MT50-06220; MT50-06221; MT50-06230; MT50-06228; MT50-05782; MT50-05743; MT50-06229; MT50-06239; MT50-06244; MT50-06238; MT50-06222; MT50-06235; MT50-06236; MT50-06227; MT50-06248; MT50-06243; MT50-06240; MT50-06231; MT50-05777; MT50-05749; MT50-05844; MT50-05942; MT50-05876; MT50-05821; MT50-05852; MT50-05822; MT50-05888; MT50-05896; MT50-05827; MT50-05854; MT50-05962; MT50-05818; MT50-05887; MT50-05833; MT50-05885; MT50-05819; MT50-05837; MT50-05884; MT50-05883; MT50-05834; MT50-05824; MT50-05889; MT50-05817; MT50-05829; MT50-05830; MT50-05832; MT50-05879; MT50-05807; MT50-05825; MT50-05823; MT50-05846; MT50-05882; MT50-05878; MT50-05831; MT50-05849; MT50-05880; MT50-05847; MT50-05877; MT50-05804; MT50-05806; MT50-05758; MT50-05763; MT50-05766; MT50-05778; MT50-05780; MT50-05781; MT50-05785; MT50-05786; MT50-05787; MT50-05788; MT50-05790; MT50-05826; MT50-05828; MT50-05850; MT50-05881; MT50-05895; MT50-06234; MT50-05995; MT50-05997; MT50-05998; MT50-06001; MT50-06002; MT50-06007; MT50-06008; MT50-06009; MT50-06010; MT50-06011; MT50-06006; MT50-06012; MT50-06015; MT50-06117; MT50-06018; MT50-05497; MT50-05519; MT50-05918; MT50-05939; MT50-05940; MT50-05941; MT50-05945; MT50-05943; MT50-05944; MT50-05947; MT50-05946; MT50-05949; MT50-05950; MT50-05951; MT50-05952; MT50-05953; MT50-05800; MT50-05851; MT50-05954; MT50-05948; MT50-05922; MT50-0592; MT50-05587; MT50-05484; MT50-05430; MT50-05493; MT50-05518; MT50-05531; MT50-05578; MT50-05585; MT50-05590; MT50-05591; MT50-05592; MT50-05593; MT50-05594; MT50-05583; MT50-05584; MT50-05588; MT50-05595; MT50-05596; MT50-05598; MT50-05599; MT50-05293; MT50-05296; MT50-05297; MT50-05301; MT50-05303; MT50-05304; MT50-05312; MT50-05324; MT50-05325; MT50-05326; MT50-05327; MT50-05328; MT50-05329; MT50-05330; MT50-05331; MT50-05332; MT50-05333; MT50-05334; MT50-05340; MT50-05305; MT50-05241; MT50 05247; MT50-05245; MT50-05246; MT50-05243; MT50-05103; MT50-05112; MT50 05118; MT 5004176; MT50-04175; MT50-04173; MT50-06242; MT50-06245; MT50-06246; MT50-06266; MT50-06268; MT50-06262; MT50-06252; MT50-06251; MT50-06247; MT50-06255; MT50-05271; MT50-05272; MT50-05273; MT50-05274; MT50-05275; MT50-05276; MT50-05277; MT50-05278; MT50-05279; MT50-05287; MT50-05285; MT50-05284; MT50-05289; MT50-05288; MT50-05286; MT50-05283; MT50-05280; MT50-05294; MT50-05281; MT50-05291; MT50-05982; MT50-05983; MT50-05984; MT50-05985; MT50-05986; MT50-05987; MT50-05988; MT50-05989; MT50-05991; MT50-05994.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AIR LIQUIDE DO BRASIL LTDA; AIR LIQUIDE MEDICAL SYSTEM DO BRASIL LTDA; Air Liquide Medical Systems.

¿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
    2304
  • Fecha
    2017-05-26
  • 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
    It alerts customers to the maintenance of the manual resusciator in perfect conditions of use and if they are properly monitored with the oximeter. #### UPDATE of the field action on 11/22/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    There were 11 cases in the world in which an unexpected stop of the ventilatory function was detected for a few seconds. in all cases, the alarm came on as expected. no cases registered in brazil.
  • Acción
    Field Action Code 1 triggered under the responsibility of Air Liquide do Brasil LTDA. Company will make field correction and installation of a 2nd machine, same model and installation of remote alarm.

Device

Monnal T50 Technical Name: Ventilator Pressure and Volume ANVISA Registration Number: 80204410020...

Manufacturer

AIR LIQUIDE DO BRASIL LTDA; AIR LIQUIDE MEDICAL SYSTEM DO BRASIL LTDA; Air Liquide Medical Systems