Events

Alerte De Sécurité sur V5Ms transesophageal transducer

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

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
    2014-09-03
  • Date de publication de l'événement
    2014-09-02
  • 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_20140903.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: siemens v5ms transesophageal transducer medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning v5ms transesophageal transducer, manufactured by siemens ltd. the affected serial numbers range from 32800000 to 42300000. the manufacturer has received recent reports about the deterioration of material covering the articulating section of the v5ms transesophogeal transducer.A compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause esophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient and the user. however, a leakage current test can indicate cracks, cuts, tears, perforations, and protrusions in the articulation material. the potential risk is avoided only if users perform the recommended leakage current test of the transesophageal transducer prior to each use. the manufacturer advises users to undertake the following steps to avoid the potential risk of this issue: perform the leakage current test for a transesophageal transducer prior to each use. use only the manufacturer approved cleaning and disinfecting solutions. use market-cleared transducer sheaths specifically designed for transesophageal echocardiogram (tee) applications. when users store the transesophageal transducer, take extreme care that the distal tip is straight. never move the distal tip by hand. always use the flex controls. the manufacturer advises customers that if they notice any damage or wear on the transducer, or if the transducer fails to pass the leakage current test, they should immediately discontinue use of the transducer and contact the manufacturer. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con448384 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2014.

Device

V5Ms transesophageal transducer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens V5Ms transesophageal transducer
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd