inforMED
MalfunctionMPO

INFANT HEEL WARMER

Received Jan 6, 2022 · Event occurred Dec 8, 2021

Report 13175130 · MDR key 13175130

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

MDS138007

Lot number

VN21174A1

Product problems

  • Insufficient Heating

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

TWO INFANT HEEL WARMERS BECAME COLD RATHER THAT WARM WHEN ACTIVATED. BOTH ARE FROM THE SAME LOT#, VN21174A1.