Events

Alerte De Sécurité sur MAQUET SERVO-air

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par MAQUET.

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
  • Date
    2017-10-10
  • Date de publication de l'événement
    2017-10-10
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171010a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: maquet servo-air the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning servo-air, manufactured by maquet [article number: 66 82 000]. all serial numbers with currently released software version 1.00.03 or older are affected. under certain conditions, the manufacturer has identified that an internal communication error might prevent the execution of the automatic failure handling process. as a consequence, ventilation will stop and a high priority alarm will be triggered. the manufacturer is aware of two instances where this issue has led to patient injury. according to the manufacturer, under normal circumstances, if a software-related error is detected, the system will resolve it automatically while ventilation continues uninterrupted. this issue will stop ventilation, with the safety and the expiratory valves open, thus allowing the patient to breathe freely, but without ventilator support. the high priority technical error alarms te43, te78, te80 and te81 will be activated simultaneously. a new system software version 2.01.02 that will correct this behavior is being developed. the manufacturer will initiate an immediate update of all affected servo-air units as soon as the system software version 2.01.02 is released. the servo-air ventilator can be used in accordance with the instructions for use, with extra attention to the following: never leave the patient unattended when connected to the ventilator system. make sure that a resuscitator is readily available. act as instructed on alarms. in case of a technical error te43, te78, te80, te81 replace the ventilator immediately and contact the manufacturer’s representative. for details, please refer to the following link: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-02-to-06-october-2017 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2017.

Device

MAQUET SERVO-air
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: MAQUET SERVO-air
  • Manufacturer
    MAQUET

Manufacturer

MAQUET