Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00464-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00464-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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 ...
  • Model / Serial
    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
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA