***The action complete deadline for this alert was
originally set at 17 December 2021 and has now been extended to 21 February
2022. The attachment has been updated to reflect the new deadline date.***
Philips have
issued 2 FSNs about selected ventilators and CPAP and BiPAP devices. These
devices are primarily used in patients with Obstructive Sleep Apnoea (OSA) and
type 2 respiratory failure.
There is a risk
of patient harm from degradation of the sound abatement foam found in these
devices. Reports of incidents related to
this issue are rare, and no incidents of harm have been reported in the UK.
There is
currently no definitive data showing long-term harm to patients, but VOCs and
degradation of the foam are associated with possible long-term effects such as:
genotoxicity; mutagenic and carcinogenic effects; hepatotoxicity;
nephrotoxicity; neurotoxicity.