Events

Avis De Sécurité sur Puritan Bennett 800 Series Ventilator System

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Covidien LP.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2013-09-12
  • Date de publication de l'événement
    2013-12-25
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/12/25/vazno-obavestenje-o-medicinskom-sredstvu-puritan-bennett-800-series-ventilator-system-model-840-respirator/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has determined, after logging in by the user of the medical device, that the ksb0069 diagnostic code occurs, causing ventilation interruption due to a software error on certain software versions of the specified system. specifically, when the specified diagnostic code appears, the fan: 1. stops delivering gases to the patient; 2. immediately initiates a high priority visual and audible alarm for the caregiver; 3. displays a red "device alert" message on the fan display; 4. illuminates the red "vent inop" and "safety valve open" leds, and opens the safety valve to allow the patient to breathe room air with spontaneous respiratory effort; i 5. displays "monitor hip fails (xb0069)" in the system diagnostic log. no injuries or fatalities were reported to the manufacturer due to the occurrence of a diagnostic code and interruption of ventilation, and the manufacturer stated precisely what the incorrect versions of the software of the specified respirator were, namely: ae-ak.

Device

Puritan Bennett 800 Series Ventilator System

Manufacturer

Covidien LP
  • 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
    ALIMSA