日期Date:16/6/2021

來源Source: 

https://www.info.gov.hk/gia/general/202106/16/P2021061600835.htm

https://www.info.gov.hk/gia/general/202106/16/P2021061600834.htm

 


 

回收特定型號Philips Respironics呼吸器
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  衞生署今日(六月十六日)接獲生產商Philips Respironics通知,由於其呼吸器的隔音泡棉易發生降解及釋放化學氣體,正自願回收特定型號呼吸器。有關呼吸器用以治療呼吸狀況,包括阻塞性睡眠窒息症。

根據生產商的公布,呼吸器使用的隔音泡棉可能會降解成微粒,並可能會進入裝置的空氣管路並由使用者攝入或吸入。此外,泡棉可能會釋放某些化學氣體。使用未經授權許可的清潔方法,可能會使泡棉的降解加劇,且在操作期間可能發生氣體釋放。

根據生產商提供的資料,約20 000台受影響的裝置已於本港出售。它們為以下型號之所有序號,並於二○二一年四月二十六日前生產的裝置:

E30(緊急使用授權);
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;及
A-Series BiPAP A30。

生產商提醒正使用上述呼吸裝置的人士,應停用裝置並與醫生商討最佳的治療方案。然而,正使用有關裝置進行生命維持治療的人士,在諮詢醫生之前,則請勿停止或改變現有的處方治療。

衞生署已通知醫院管理局、私家醫院、護理院舍及醫療專業人員有關回收。

衞生署發言人說:「本署至今沒有接獲在本港使用與受影響裝置相關的不良事件的報告。」

發言人補充:「市民如正使用受影響裝置,請致電生產商設立的熱線(2821 5797)查詢及跟進,服務時間為星期一至六上午九時至下午六時。」

2021年6月16日(星期三)
香港時間21時15分

 

Recall of certain models of Philips Respironics ventilators
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     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.

Ends/Wednesday, June 16, 2021
Issued at HKT 21:15
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