Events

Rappel de Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ulco Engineering Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01172-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01172-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Mindray has identified the following issues:- the 12-lead standard and extended measurement report will include false measurements when the p wave or qrs axis cannot be accurately determined by the algorithm. - the median complex and extended measurement report will display the representative beat as 25% larger than actual signal input. - when a patient date of birth is imported into the v-series from an external source, such as mindray’s gateway, e-gateway, panorama central station or panorama workstation, the age will not pass into the 12-lead ecg interpretation algorithm. the algorithm analysis will use the default adult criteria of “50 year adult” in which case the interpretive statements may be incorrect, depending on the actual age of the patient. any output of the 12-lead ecg interpretation data (e.G. printed records, ecg management system, etc.) will include the issues described above. there have been no reports of injuries associated with these issues.
  • Action
    Mindray is recommending that users discontinue use of the affected units until the software correction is completed. This action has been closed-out on 26/08/2016.

Device

Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities
  • Modèle / numéro de série
    Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilitiesV-series Model Numbers: 1409 & 1410Serial Numbers: EGD16006409, EGD13004678 & EGD0B002460ARTG Numbers: 223384
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA