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News & Trends - Medical Technology

Stryker and TGA issue urgent Product Defect Correction for defibrillator

Health Industry Hub | April 7, 2021 |
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MedTech News: Stryker, in consultation with the Therapeutic Goods Administration (TGA), is undertaking a Product Defection Correction to update the operating instructions of all LIFEPAK CR2 defibrillators and will be providing replacement parts where appropriate.

Stryker has become aware that the lid magnet for this device can occasionally become separated and lost. Until recently, Stryker was only aware that if the lid magnet is missing, the device would not automatically turn on and off when the lid is opened and closed.

Stryker has now become aware that if the lid magnet is missing, it also causes the LIFEPAK CR2 battery to deplete more quickly resulting in premature battery life. The LPCR2 Operating Instructions currently provide users with no warning that the battery can become prematurely depleted if the lid magnet is missing.

According to the TGA, there have been two reported deaths in relation to this issue worldwide. There have been no reported injuries or deaths within Australia.

LIFEPAK CR2 defibrillators are automated external defibrillators (AEDs) used in cases of life-threatening cardiac arrhythmia or cardiac dysrhythmia that leads to cardiac arrest.

To address this issue, Stryker recommends all LIKEPAK CR2 AEDs be checked carefully to ensure their lid magnets are securely in place. Where a lid magnet has been dislodged, Stryker will be providing replacement lids at no charge.

Supplemental instructions are being sent to all owners of these devices, along with a letter about this issue (including details of which serial numbers have defective lid magnets and which do not, but should still be checked). This may help reduce the risk until replacement parts can be provided by Stryker.


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