BREAKING NEWS Urgent recall for life-saving device over dangerous defect
The federal government issued a notice for medical technology firm Stryker's HeartSine samaritan Public Access Defibrillator (PAD) on June 24.
'A manufacturing problem related to a circuit board component may impair the device's ability to function or cause failure,' it said.
'This failure could occur at any point when the device is holding a charge.
This may be in preparation to deliver therapy, while delivering a shock, or after shock delivery.
'The device becomes inoperable after the failure occurs.'
The notice said the defect was spotted during quality testing, not patient use.
The source of the issue was the Pad-Pak, a single-use battery and electrode cartridge containing the battery to power the defibrillator and two electrode pads.
Users should check their AED serial number to see if it is affected, noting the devices are part of a subset of HeartSine samaritan PAD Models 350P, 360P, 450P and 500P.
The affected devices are part of a subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H.
Stryker said users should continue monitoring their PAD device to ensure the status indicator is flashing green every five to 10 seconds.
They should contact Stryker immediately if the status indicator is flashing red, or they can hear continuous beeping or the voice prompt 'Warning, Low Battery'.
Alternatively, they should contact the company if no status indicator is displayed.
For further information, Stryker can be reached on 02 9170 9131 or through email at heartsine.recall@stryker.com.
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