Medical device manufacturer, Philips, has issued a medical device safety alert concerning its HEARTSTART DEFIBRILLATION PADS [Model number: M5072A-ABA, Lot or serial number: Y111220-01]
A problem has been identified in certain Philips M5072A HeartStart Infant/Child SMART Pads Cartridges which are used with the Philips HeartStart OnSite and HeartStart Home Automated External Defibrillators (AEDs). Some of the affected products contain an incorrect image on the protective cover seen underneath the PULL handle. The image on the protective cover should show a drawing of pads placement for a child's chest and back. However, some M5072A Infant/Child SMART Pads Cartridges from LOT Number Y111220-01 incorrectly show the pads placement for an adult's chest on the inner layer protective cover.
An affected product containing an incorrectly printed protective cover can cause therapy delay and/or delivery of lower energy than indicated for an adult patient. To date, from over 19,000 pads cartridges from this lot Number, the manufacturer has received customer complaints for 11 cartridges for the incorrect image. No patient harm was reported for these 11 instances.
According to the manufacturer, it will provide replacement M5072A Infant/Child SMART Pads Cartridges. It also advises the following actions to affected users:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please check your products and contact your supplier for necessary action.
Posted on 27 Aug 2021