Events

Field Safety Notices about Puritan Bennett 800 Series Ventilator System

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Covidien LP.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2013-09-12
  • Event Date Posted
    2013-12-25
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/12/25/vazno-obavestenje-o-medicinskom-sredstvu-puritan-bennett-800-series-ventilator-system-model-840-respirator/
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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