| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00464-1 |
| Product Name/Description |
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 Advanced
BiPAP autoSV
ARTG Numbers: 217362, 209934, 133793 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1300 766 488 Philips Sleep & Respiratory Care Customer Care Centre |