Events

Field Safety Notices about BiPAP autoSV Advanced System One and others

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by KONINKLIJKE PHILIPS.

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
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Resmed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with reduced left ventricular ejection fraction (lvef ≤ 45%), 10.0 percent of the asv group experienced a cardiovascular death each year compared to 7.5 percent of the control group, representing a 33.5 percent relative increased risk of cardiovascular mortality (hr=1.335, 95%ci=(1.070, 1.666), p‐value= 0.010). philips is actively evaluating the information provided by resmed and examining if this might impact the medical care of patients who use the philips devices listed above.

Device

BiPAP autoSV Advanced System One and others

Manufacturer

KONINKLIJKE PHILIPS
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS