Events

Safety Alert for Adaptive-Servo-Ventilation Therapy

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by ResMed Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-05-14
  • Event Date Posted
    2015-05-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150514a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: resmed adaptive-servo-ventilation therapy medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning ventilators with adaptive servo-ventilation (asv), manufactured by resmed limited. the affected devices are identified as follows:- autoset cs, autoset cs pacewave, autoset cs2, autoset cs-a, vpap adapt, vpap adapt sv, vpap adapt sv-a, vpap tx, s9 autoset cs, s9 autoset cs pacewave, s9 autoset cs-a, s9 autoset cs-a pacewave, s9 vpap adapt, s9 vpap adapt easv, s9 vpap adapt pacewave, s9 vpap tx, aircurve 10 asv, aircurve 10 cs pacewave, lumis tx a serious safety concern has been identified during the preliminary primary data analysis from the serve-hf clinical trial. this trial investigated the effect of asv therapy on the hospitalisation and mortality rate of patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and moderate to severe predominant central sleep apnea (ahi ≥ 15/h, cahi/ahi ≥ 50% and cai ≥ 10/h). the identified safety concern is a significant increase in the risk of cardiovascular death in patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) being treated with asv. mhra recommends affected users to take the following actions:- physicians managing patients with symptomatic chronic heart failure with reduced ejection fraction who are using resmed asv devices should contact their patients to discuss discontinuation of treatment. physicians should assess all patients currently being treated with asv mode for symptomatic chronic heart failure and if necessary undertake an assessment of lvef. where appropriate discontinuation of treatment needs to be discussed with patients physicians should be aware that new at risk patients should not use asv. asv therapy is now contraindicated in these at risk patients for details, please refer to the mhra websites:https://mhra.Filecamp.Com/public/file/28rq-imk5u9imhttps://www.Gov.Uk/drug-device-alerts/specific-resmed-ventilators-with-adaptive-servoventilation-asv-increased-risk-of-cardiovascular-death-in-patients-who-have-a-specific-heart-condition posted on 14 may 2015.

Device

Adaptive-Servo-Ventilation Therapy
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ResMed Adaptive-Servo-Ventilation Therapy
  • Manufacturer
    ResMed Limited

Manufacturer

ResMed Limited