Events

Alerte De Sécurité sur Puritan Bennett 980 Universal Ventilator 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 Medtronic.

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
    2016-01-25
  • Date de publication de l'événement
    2016-01-25
  • 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_20160125a.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: medtronic puritan bennett 980 universal ventilator system medical device manufacturer, medtronic, has issued a medical device safety alert concerning all models of its puritan bennett 980 (pb980) ventilator for the following two issues: 1. graphical user interface (gui) unresponsive to touch in this situation, the ventilator continues to operate at existing settings, all real-time waveforms and pressure/volume measurements, as well as alarm functions and the bezel keys (hard keys below the touch screen), remain active. however, in this situation, users are unable to change ventilator settings or the configuration of the gui display. should this occur, the clinical team should transfer the patient to another ventilator.The frequency of occurrence based on reported complaints is 1.3%, corresponding to an annual rate of 0.7%. 2. loss of primary ventilation under certain circumstances the manufacturer has received reports of the pb980 ventilator losing primary ventilation capabilities, in which case the backup ventilation (buv) design feature is activated.When buv is initiated, high urgency audio and visual alarms are annunciated immediately and cannot be silenced. the clinical team should transfer the patient to another ventilator. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, in which case, by design, the ventilator opens all valves to atmospheric pressure and room air, and ventilation ceases. high urgency audio and visual alarms are annunciated. the clinical team should transfer the patient to another ventilator. the manufacturer’s investigation revealed that background diagnostic software responsible for monitoring ventilator system function inappropriately determines a hardware problem exists. the ventilator then moves to buv and occasionally into ventilator inoperative. as stated above, when this occurs the clinical team should transfer the patient to another ventilator. the frequency of occurrence based on reported complaints is 1.6% corresponding to an annual rate of 0.9%. approximately 50% of these events occurred at ventilator power-on/start-up. affected users may continue to use their pb980 ventilators. they are advised to ensure patients on pb980 ventilators are appropriately monitored by medical personnel and suitable monitoring devices as described in the operator’s manual. the manufacturer will develop and implement corrections for these issues. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 january 2016.

Device

Puritan Bennett 980 Universal Ventilator System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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