HeartStart FRx and HeartStart HS1 automated external defibrillators 의 안전성 경고

Safety alert

2013-12-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131204a.html

Safety alert on philips heartstart frx and heartstart hs1 automated external defibrillators the department of health (dh) today (december 4) drew the public's attention to a safety alert issued by philips healthcare concerning its three models of automated external defibrillators (aeds), namely heartstart frx, heartstart hs1 home and heartstart hs1 onsite, as the devices may be unable to deliver the needed electric shock in a cardiac emergency situation. the dh, through its routine surveillance on medical devices, noticed the above alert from the us food and drug administration. according to philips healthcare, the devices manufactured between 2005 and 2012 could incorrectly indicate that they are ready for use yet be unable to deliver the needed electric shock. according to the local supplier, philips electronics hong kong ltd, the affected models are marketed in hong kong as heartstart frx and heartstart hs1. the dh's enquiries with the supplier revealed that 374 units of heartstart frx and heartstart hs1 have been distributed to hospitals, clinics, schools and other venues. a dh spokesman said, "all owners of the affected aeds are advised to contact their supplier for technical support and advice. they should keep the affected aeds in service until such advice or a replacement is available." "so far, the dh has not received any relevant reports of adverse incidents related to the affected aeds in hong kong," the spokesman added. the company has set up a customer service hotline, 800 969 619, to answer related enquiries. the dh has informed public and private hospitals and relevant associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends/wednesday, december 4, 2013 issued at hkt 20:46.