Heartstart Defibrillation Pads (2018-08-10)
- Starting date:
- August 10, 2018
- Posting date:
- August 31, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67628
Affected products
Heartstart Defibrillation Pads
Reason
One side of the foil pouch containing the Heartstart Infant/Child Smart Pads Cartridge (M5072A) contains text incorrectly stating "8+ years." elsewhere, larger type "0-8" with "pink teddy bear" icon, and a picture of a small child are correctly printed on both sides of the pouch. Importantly, the labeling on the cartridge itself and on the box in which the cartridge is supplied is accurate.
If users read the small printed text on the pouch, they could be confused about the age range for which the infant/child cartridge is intended. An infant/child pads cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the adult pads cartridge and may therefore not be effective on an adult. To date, however, Philips has not received any reports of any harm or confusion due to this printing error.
Philips is conducting a voluntary recall of infant/child cartridges in the misprinted pouches.
Affected products
Heartstart Defibrillation Pads
Lot or serial number
More than 1000 numbers, contact manufacturer.
Model or catalog number
M5072A
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
UNITED STATES