Events

Alerta De Seguridad para Monnal T 50 Technical Name: Ventilator Pressure and Volume ANVISA Registration Number: 80204410022 Hazard Class: III Affected Model: 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
    2303
  • 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
    Elaboration of letter to the client with the orientation of use of the second machine as exposed in the action plan and contact with the company's SAC. #### 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
    During any patient procedure in which it is necessary to put into standby mode (for example, when placing it for respiratory exercise or when changing disposables of the equipment). the appearance of a black screen was observed in four cases, without loss of the original settings, but with interruption of the machine operation and alarm activation. in these situations, only manual ventilation or equipment replacement options can normalize the patient's condition.
  • Acción
    Field Action Code 3 triggered under the responsibility of Air Liquide do Brasil LTDA. Company will make field corrections and send letters to clients.

Device

Monnal T 50 Technical Name: Ventilator Pressure and Volume ANVISA Registration Number: 8020441002...

Manufacturer

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