Philips—HeartStart Infant/Child SMART Pads Cartridges: Protective Cover May Incorrectly Show ​Application to Adult

August 11, 2021 | Strategic Insights for Health System


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Problem: ​In a July 26, 2021, Urgent Medical Device Removal letter submitted by an ECRI member hospital, Philips states that the image on the protective cover of the above defibrillator pads should show a drawing of pads placement for a child's chest and back (see Figure 1 in the letter); however, the inner layer protective cover may incorrectly show pads placement for an adult's chest (see Figure 2 in the letter). Philips also states that the image is correct on the outer pouch that contains the infant/child pads cartridge (see Figure 3 in the letter). Philips further states that the following...

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