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

August 29, 2018 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

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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