Events

Alerte De Sécurité sur cardiovit at-102 plus

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

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
    2017-02-08
  • Date de publication de l'événement
    2017-02-08
  • 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_20170208b.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: schiller medical cardiovit at-102 plus medical device manufacturer, schiller medical, has issued a medical device safety alert concerning its cardiovit at-102 plus (software version: 1.21; 1.22 or 1.23 and article number: 0.075000) it has recently come to the manufacturer’s attention that patient data mix-up may happen when the setting of “manual send” and “automatic erase after send” is chosen for the data transmission. according to the manufacturer, electrocardiography (ecg) data interchange only happens with this particular setting. all other settings are not affected. the occurrence is evaluated as rare, considering the limited number of incident reports in relation to the number of ecgs made per year and due to the fact that most customers use auto transmission, and additionally to the fact that data interchange is not likely to happen if the patient is released from the cables before the manual ecg transmission is started. the affected users are advised to check their stock and devices on the field to identify the software version of cardiovit at-102 plus. if the software version is either 1.21, 1.22 or 1.23, they need to take actions as recommended below. until receiving a new software version of cardiovit at-102 plus from the manufacturer, affected users are advises to take one of the following three settings to prevent the occurrence of the patient safety issue: automatic send with automatic erase of data after sending automatic send without automatic erase of data after sending manual send without automatic erase of data after sending the manufacturer will deliver a new software version to address this issue and will be released by february 2017. according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 february 2017.

Device

cardiovit at-102 plus
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CARDIOVIT AT-102 Plus
  • Manufacturer
    Schiller Medical

Manufacturer

Schiller Medical