Philips Recall: Field Safety Notice

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The Health Service Executive (HSE) has made Children’s Health Ireland (CHI) aware of a Field Safety Notice (FSN) by the manufacturer Philips relating to ventilation devices for a number of positive airway pressure (PAP) devices used for treatment of sleep apnoea and respiratory failure.

Some of the machines listed in the recall are in use in Children's Health Ireland (CHI) hospitals in Crumlin, Temple Street and Tallaght, and with patients in the community.

The Health Products Regulatory Authority (HPRA) in Ireland, safety regulator for medicines and devices for people and animals, is monitoring this situation from an Irish perspective. Click here to for HPRA Safety Notice.

The HSE and HPRA have issued separate statements on the Philips Safety notice. The HSE will continue to work with the HPRA to make additional information and guidance available.

Based on current information supplied by Philips, the HSE recommends that all patients and device users continue to use their device as prescribed until a replacement device is supplied or the device repaired. Click here for HSE update.

Air Liquide, the company in Ireland that provides healthcare devices, is managing machines affected in Ireland. CHI has been in contact with Air Liquide about this issue, and continues to monitor the situation.

CHI awaits further information from the manufacturer before our clinical experts and health specialists can provide further advice to patients. In the interim, the HSE advises patients to continue using their device as prescribed by their doctor. If any patient or carer has concerns regarding the device they are using, they are advised to check the device serial number and to contact the company who supplied their device for further information. Patients should contact their doctor if they have any further concerns.

Should you have any further queries and wish to speak to a CHI member of staff please contact our helpline for parents Monday-Friday 9am-5pm, Tel +353 1 409 6715.

Further information, a statement and FAQ document is available on the HSE website, latest news section.

For further information or support from Philips contact 1800 851 241 or see Sleep and respiratory care update | Philips.

Helplines

-       Should you have any queries or questions please contact the Air Liquide Helpline at 1800 240 2020.

-       For further information or support from Philips contact 1800 851 241 or see Sleep and respiratory care update | Philips

-       Children’s Health Ireland have a helpline for parents Monday-Friday 9am-5pm, Tel +353 1 409 6715

 

ENDS