Events

Alerte De Sécurité sur Puritan Bennett 840 Ventilator

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

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
    2014-06-10
  • Date de publication de l'événement
    2014-06-09
  • 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_20140609.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: covidien puritan bennett 840 ventilator the australia therapeutic goods administration (tga) posted a medical device safety alert concerning puritan bennett 840 ventilator manufactured by covidien. the affected ventilator serial numbers are 3510102854, 3510102868, 3510102839, 3510102853, 3510102849, 3510102848 and 3510102852, and the serial numbers of the affected power supply units are 39302, 40221, 40355, 40465, 40324, 40327 and 40450. the manufacturer has received customer reports of the loss of graphical user interface (gui) display information while the ventilator continues to provide breath support. customer reports describe the gui display screens (both upper and lower) becoming blank during patient use. this event interferes with the clinician's ability to view and/or change ventilator setting or clinician-set patient alarm parameters. loss of gui display due to a power supply unit (psu) failure is demonstrated by the ventilator entering a “gui inop” state i.E. if the breath delivery unit (bdu) loses communication with the gui, the bdu recognises this and enters a “gui inop” state. it initiates the appropriate alarm consisting of a visible alarm indicated by the illumination of the “gui inop” red light on the bdu and a high-priority audible alarm. the source of the psu voltage loss is a specific circuit responsible solely for the gui central processing unit voltages. a representative from the manufacturer will perform an inspection of affected ventilator(s) to determine if it has the affected component and if so, will replace the psu immediately. if users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability i.E. confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring parameters (e.G., oxygen saturation, heart rate, blood pressure, etc). also, the manufacturer advises users to promptly transfer the patient to an alternate ventilator in a manner consistent with the institutional protocol and remove the affected ventilator from use until it has been serviced. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00618-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 june 2014.

Device

Puritan Bennett 840 Ventilator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Covidien Puritan Bennett 840 Ventilator
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH