MalfunctionMPO
ATLANTICMED INFANT HEEL WARMER
Received Mar 7, 2025 · Event occurred Jan 18, 2025
Report 21546572 · MDR key 21546572
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Jiangsu Intco Medical ProductsModel number
ATL-IFW-0305Catalog number
ATL-IFW-0305
Lot number
C0012212-1
Patient
12 DA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THIS BRAND OF INFANT HEAL WARMERS ROUTINELY BURST. TODAY IT POPPED AND GOT SEDIMENT ALL OVER MY INFANT PATIENT'S FEET. MOTHER WAS VISIBLY UPSET. INFANT WAS UNHARMED. RN WENT TO SUPPLY ROOM TO GET A NEW ONE AND ANOTHER ONE POPPED PRIOR TO APPLYING TO PATIENT.