Events

Rappel de Puritan Bennett 840 Ventilator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00618-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-06-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00618-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Covidien 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.
  • Action
    A Covidien representative will perform an inspection of affected ventilator(s) to determine if it has the affected component and if so, will replace defective PSU immediately. If users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability ie, 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 (e.g., oxygen saturation, heart rate, blood pressure, etc). Also, users are advised 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. This action has been closed-out on 02/02/2016.

Device

Puritan Bennett 840 Ventilator
  • Modèle / numéro de série
    Puritan Bennett 840 VentilatorPower Supply Serial Numbers: 39302, 40221, 40355, 40465, 40324, 40327, 40450Vent Serial Numbers: 3510102854, 3510102868, 3510102839, 3510102853, 3510102849, 3510102848, 3510102852ARTG Number: 182309
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 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
    DHTGA