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A WARNING HAS been issued over unauthorised labels on some defibrillator pads which display an incorrect expiry date.
The Health Products Regulatory Authority (HPRA) today said that a number of Defibtech Automated External Defibrillator (AED) pads supplied to the Irish market have been affixed with unauthorised labels.
These unauthorised labels, which the HPRA said were applied outside of Defibtech’s control, provide an incorrect expiry date.
The HPRA warned that this could result in expired AED pads being used after their shelf life.
This in turn could result in a poor electrical connection and reduced energy delivered to a patient.
Defibtech has issued a Field Safety Notice (FSN) to customers highlighting the issue.
The FSN details how to identify an affected AED pad and outlines the actions required to arrange for the removal and exchange of an affected AED pad.
The HPRA has also directly contacted a number of organisations that could be impacted and is urging users to immediately check their AED pads.
The HPRA is the regulatory authority for medical devices in Ireland, and Defibtech is working with it to further investigate the matter and its impact on customers, as well as to assess the total number of pads affected.
It’s understood that the authorised labels on a number of AED electrode pads were removed and an unauthorised label was then applied outside of Defibtech’s control.
This could potentially lead to an expired AED Pad appearing as though it is within the acceptable use range.
The affected AED Pads are for exclusive use with Defibtech AED models and include:
Defibtech and the HPRA are advising customers who have one of the Defibtech AED models listed and have purchased Defibtech AED pads to immediately inspect the product label.
Those with affected products should contact Oxygen Care, Defibtech’s new Irish market distributor, to arrange a return and exchange for an authorised labelled Defibtech AED Pad free of charge.
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Extremely serious but not as extreme as political point scoring over Sinn Féin, Cairns and Bacik were a disgrace, both of whom will readily join the next government, knowing that they won’t play a significant role and most left in regards to child protection but hey, they got their 15 minutes on attacking Sinn Féin in managing complaints very well. Does the British Heart Foundation not vet employees? Sorry, that doesn’t help in attacking Sinn Féin. Mislead the Dáil but reported it to the PSNI, is it the Dáil we’re meant to feel sorry for not being given an opportnuity beforehand to attack Sinn Féin. What about a review of all parties, haven’t heard that suggested and it won’t happen, the establishments skeleton’s in the closet will remain just that. The Grace case should be interesting.
@Brian D’Arcy: even a defibrillator would be no good to Sinn Fein now, there’s no coming back for them
@Fredrick Dooley: it’s a non story designed to deflect from the sorry state of affairs the country is in .
24 billion surplus we are told but cant stop over 600 people being on trolleys .
A joke of a govt
@sean weir: a worse opposition, in fact, no opposition
@Brian D’Arcy: typical of Sf referring to the alleged victims ‘trauma’. You either think this is smart politics or a cheap smear. The latter for me. Why couldn’t they wait and let the gardai pursue their investigation (of what wasn’t a criminal offence until SF decided to categorise it as such.
@sean weir: what can the government do about the HSE there’s only so much money you can through at a black hole and no matter who is in government this situation will be the norm. The HSE needs to be gutted broken up and redesigned an audit done in every hospital who is actually working and what are there rolls also some positions should amalgamated allowing funding to employ more much needed doctors nurses. Actual triage units external to ED need to be set up and ED only used for emergencies not when little Johnny has a sniffle or the shitz either that or charge time wasters those with medical cards especially.
Well…the previous supplier of these allegedly “date doctored” defibrillator pads was not named. Surely that’s a criminal offence – tampering with essential ancillary products that are necessary for medical devices to be effective?? These are not just “sticky pads” but contain the electrical conductor gel for the defibrillator paddles to make effective contact through to the receiving person’s body. PS – I’m not a medical equipment engineer – so please correct me if I’m wrong…
A shocking situation.
PEOPLE WILL DIE!! ENQUIRY NOW
This is not as shocking as it should be.
You could just say they lose their stickiness
Least tea bags never out of date
@Shawn: There’s generally two years on them.
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