The Department of Health (DH) today (June 16) received a notification from manufacturer, Philips Respironics, on its voluntary recall of certain models of ventilators, used for treating respiratory conditions including obstructive sleep apnea, due to sound abatement foam susceptible to degradation and chemicals emission from the devices.
As announced by the manufacturer, the sound abatement foam used in the ventilators may degrade into particles which may enter the device's air pathway and be ingested or inhaled by user. Besides, the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, and off-gassing may occur during operation.
According to the manufacturer, about 20 000 affected devices were sold in Hong Kong. They were manufactured before April 26, 2021 of the following models with all serial numbers:
E30 (Emergency Use Authorisation);
DreamStation ASV;
DreamStation ST, AVAPS;
SystemOne ASV4;
C-Series ASV;
C-Series S/T and AVAPS;
OmniLab Advanced+;
SystemOne (Q-Series);
DreamStation;
DreamStation Go;
Dorma 400;
Dorma 500;
REMstar SE Auto;
Trilogy 100;
Trilogy 200;
Garbin Plus, Aeris, LifeVent;
A-Series BiPAP Hybrid A30;
A-Series BiPAP V30 Auto;
A-Series BiPAP A40; and
A-Series BiPAP A30.
The manufacturer advises that users of the above devices should discontinue using them and work with their physician on the appropriate options for continued treatment. However, for those using the devices for life-sustaining therapy, they should not stop or alter their prescribed therapy before consulting their physician.
The DH has alerted the Hospital Authority, private hospitals, nursing homes, and medical professional of the recall today.
"So far, the DH has not received any reports of adverse event related to using the affected devices in Hong Kong," a spokesman of the DH said.
"If you are using any of the affected devices, please call the hotline set up by the manufacturer (2821 5797) for enquiries and follow-up from 9am to 6pm on Mondays to Saturdays," the spokesman added.
Reposted from HKSAR Government webpage:
https://www.info.gov.hk/gia/general/202106/16/P2021061600834.htm
- 2021.06.16