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
    2013-12-16
  • Date de publication de l'événement
    2013-12-16
  • 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_20131216.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 medical device manufacturer, covidien private limited issued a medical device safety alert concerning puritan bennett 840 ventilator. the affected part number is4-070000-85 and the impacted software versions are ae to ak. the manufacturer is conducting a voluntary field correction on puritan bennett 840 ventilator systems with certain software versions in response to customer reports of ventilator diagnostic code xb0069 in which the device stops mechanical ventilation due to a software error. the frequency of occurrence of this code is low, and in asia,the manufacturerhas not received any reports related to this issue. according to the manufacturer, the issue only impacts certain software versions. for those software versions, the two scenarios in which diagnostic code xb0069 can potentially occur are the following: when the patient can generate a strong spontaneous effort with a sustained expiratory flow rate of >90 l/min for ≧ 0.4 seconds and the difference between the set peep and high pressure alarm is ＜35cm h2o. when using volume control mode with an inspiratory time of ＞0.4 seconds and with leak compensation being enabled. the manufacturer has developed a software solution to address this issue. until the software is updated, users will need to remain vigilant regarding this issue. the manufacturer advises users to always follow the instructions as described in the puritan bennett 840 operator’s manual. 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 16 december 2013.

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