Events

Alerte De Sécurité sur RPM Respiratory Gating System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Varian 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
  • Date
    2013-04-08
  • Date de publication de l'événement
    2013-04-08
  • 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_20130408.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: varian rpm respiratory gating system medical device manufacturer, varian medical systems has issued a medical device safety alert concerning real-time position management (rpm) respiratory gating systemv1.7.5 with 3d option. an anomaly has been identified with the rpm respiratory gating system software version 1.7.5, 3d option. while operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. trace inversion occurs when the breathing trace on the chart window moves in a phase opposite to the marker block movement. this event has been reported in an extremely limited number of times in the installed base, but users should be aware and monitor their displays carefully. the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-dot marker block during a calibration sequence, a reference session, or a single session after tracking has begun. in practice, this has been extremely rare. the root cause of the malfunction has been determined to lie within the smarttrack software library used only by rpm v1.7.5 with the 3d option. therefore, the manufacturer has developed a technical correction for this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 april 2013.

Device

RPM Respiratory Gating System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian RPM Respiratory Gating System
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems