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)
Manufacturer
Cardinal Health 200, Llc.Model number
V11460-010Catalog 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.