Events

Rappel de Philips Respironics Devices used for Auto Servo-Ventilation Therapy:BiPAP autoSV Advanced System One (60 Series)BiPAP autoSV Advanced System One (50 Series)BiPAP autoSV Advanced w/SmartCard (SV3)BiPAP autoSV w/SmartCard (SV2)OmniLab Advanced +OmniLab AdvancedBiPAP autoSV

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00464-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00464-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Resmed has issued an recall for product correction notice (tga ref.: rc-2015-rn-00405-1) that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomised to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with 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 respironics is actively evaluating the information provided by resmed and examining if this might impact the medical care of patients who use the affected devices above.
  • Action
    Until Philips Respironics complete their investigation, based on the ResMed data, clinicians are strongly recommended to adhere to the recommendations cautioning against the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF=45%, AND moderate to severe predominant central sleep apnea. Physicians prescribing ASV therapy are recommended to evaluate current patients; a discussion about whether to discontinue ASV therapy should occur if a current patient is found to be in the at-risk population AND not place new patients in the at-risk population on the devices. Therefore, as a precaution, physicians should assess individual risks before prescribing therapy with these devices for the at-risk patient population. This action has been closed-out on 05/09/2016.

Device

Philips Respironics Devices used for Auto Servo-Ventilation Therapy:BiPAP autoSV Advanced System ...
  • Modèle / numéro de série
    Philips Respironics Devices used for Auto Servo-Ventilation Therapy:BiPAP autoSV Advanced System One (60 Series)BiPAP autoSV Advanced System One (50 Series)BiPAP autoSV Advanced w/SmartCard (SV3)BiPAP autoSV w/SmartCard (SV2)OmniLab Advanced +OmniLab AdvancedBiPAP autoSVARTG Numbers: 217362, 209934, 133793
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA