Events

Alerte De Sécurité sur Maternal and Fetal Monitor (Model: SRF618X9) (STAN S41)

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

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
    2018-06-22
  • Date de publication de l'événement
    2018-06-22
  • 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_20180622a.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: guangzhou sunray maternal and fetal monitor (model: srf618x9) (stan s41) medical device manufacturer, guangzhou sunray medical apparatus co., ltd., has issued a medical device safety alert concerning its maternal and fetal monitor [model: srf618x9, stan s41; article number: p1271-05044]. the manufacturer had received several complaints of intermittent inaccurate ultrasound-derived fetal heart rate recordings by the maternal and fetal monitor (model: srf618x9, software version 3.5 and 3.8). according to the manufacturer, the root cause has been identified to be software-related. the inaccurate ultrasound-derived fetal heart rate recordings may lead to none or delayed intervention, resulting in severe injury or death to the fetus. the manufacturer has corrected this issue in software version 3.9 which will: change the principle regarding which fetal heart rate values are interconnected with a line in the ctg trace; increase specificity of presented fetal heart rate values from ultrasound recording. the change is intended to reduce the ratio of false fetal heart rate values presented when the input signal is weak, i.E. when no audible feedback from the fetal heart heard through can be heard through the loudspeaker. the affected users are advised to take the following actions: contact the service representative to schedule the upgrade of the system; during monitoring, the users should note that the on-going evaluation of the recorded trace requires regular confirmation that the trace represents true fetal heart rate; during the monitoring, if there is any concern that the fetal heart rate tracing is not accurate, take additional steps to confirm the fetal heart rate by using: an obstetric stethoscope; ultrasound imaging; a fetal scalp electrode. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2018.

Device

Maternal and Fetal Monitor (Model: SRF618X9) (STAN S41)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Guangzhou Sunray Maternal and Fetal Monitor (Model: SRF618X9) (STAN S41)
  • Manufacturer
    Guangzhou Sunray Medical Apparatus Co.

Manufacturer

Guangzhou Sunray Medical Apparatus Co.