Events

Alerte De Sécurité sur 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.

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
    2304
  • 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
    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.
  • Cause
    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.
  • Action
    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