inforMED
MalfunctionMPO

NOVAPLUS INFANT HEEL WARMER

Received Jun 20, 2024 · Event occurred Feb 14, 2024

Report 19574436 · MDR key 19574436

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

V11460-010

Catalog number

V11460-010

Patient

2 DA · Female

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

Narrative

Description of Event or Problem

REGISTERED NURSE (RN) ACTIVATED THE HEEL WARMER AS USUAL AND PLACED IT ON INFANT¿S HEEL. NURSE BEGAN ASSESSMENT AND MID ASSESSMENT (~2 MINUTES), THE HEEL WARMER POPPED/EXPLODED AND THE CONTENTS SPLATTED AGAINST INSIDE OF ISOLETTE- ON BLANKETS, WALL OF ISOLETTE AND OUT OF PORTHOLE DOOR ONTO FLOOR. SEAM POPPED OPEN, CONTENTS OF PACKAGE WENT ON INFANT¿S BILATERAL LOWER LEGS, BELOW THE KNEES, AND BEDDING CHANGED. HEEL WARMER PROMPTLY REMOVED AND INFANT CLEANED OF CONTENTS.