MalfunctionMPO
ATLANTICMED
Received Aug 25, 2025 · Event occurred Jul 16, 2025
Report 22886305 · MDR key 22886305
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Atlantic Trading LlcModel number
ATL-IFW-0305Catalog number
ATL-IFW-0305
Lot number
C0012212-1
Product problems
- Insufficient Heating
- Defective Device
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HEEL WARMERS DEFECTIVE, NOT ABLE TO ACTIVATE WARMING DISC. DID NOT REACH THE PATIENTS.