Philips—​HeartStart Infant/Child SMART Pads Cartridges: Foil Pouch May Be Labeled with Incorrect Age Group

August 29, 2018 | Strategic Insights for Health System


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In an August 6, 2018, Customer Information letter submitted by ECRI Institute member hospitals, Philips states that one side of the foil pouch of the above defibrillator pads incorrectly states the age range as 8+ years; however, larger type elsewhere on both sides of the pouch, accompanied by a pink teddy bear icon, correctly states the age range as 0 to 8. Philips also states that the labeling on the cartridge box and the cartridge itself is correct. Philips has received no reports of patient harm as a result of this problem. The manufacturer has not confirmed the...

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