Philips Electronics Australia Ltd — Philips M5072A Infant/Child SMART Pads Cartridge - External Defibrillator Electrode

PRA number

2021/19220

Published date

Product description

Philips M5072A Infant/Child SMART Pads Cartridge

Catalogue number: M5072A

Lot number: Y111220-01

ARTG 337265
(Philips Electronics Australia Ltd - External Defibrillator electrode, Paediatric, single use)

Photograph of Philips M5072A InfantChild SMART Pads Cartridge Packaging Images

What are the defects?

Certain M5072A Infant/Child SMART Pads Cartridges (LOT Number Y111220-01) contain an incorrect image underneath the PULL handle on the protective cover that shows the pad placement for an adult’s chest (Figure 2).

The image on the protective cover should show a drawing of pad placement for a child’s chest and back (Figure 1).  The image is correct on the outer pouch that contains the infant/child pads cartridge (Figure 3).

What are the hazards?

In an emergency, if the use and/or placement of the pads is not clear to the user, there may be a delay in administering the defibrillation shock and this may increase the risk of injury to the patient.

What should consumers do?

Consumers should contact the place of purchase to arrange for replacement of the product.

As replacement pads and cartridges may not be immediately available, users should determine whether the Infant/Child SMART Pads should remain in service until replaced by referring to the guidance in Philips' customer letter.

Affected pads and cartridges should be discarded after the replacement product has been received.

For further information, please contact Philips Service Delivery Team by phone on
1800 251 400.

Traders who sold this product

Philips Electronics Australia distributors

Where the product was sold

Online
New South Wales
Queensland
South Australia
Victoria
Western Australia
Australian Capital Territory
Northern Territory

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category