Events

Alerte De Sécurité sur 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.

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

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
    2303
  • Date
    2017-05-26
  • 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
    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.
  • Cause
    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.
  • Action
    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