inforMED
MalfunctionNSA

HeartStart

Received Jul 30, 2026

Report 3030677-2026-100815 · MDR key 50086751

Device

Generic name

Over-the-counter Automated External Defibrillator

Model number

HeartStart HS1

Catalog number

M5066A

Lot number

05688P

Product problems

  • Failure of Device to Self-Test

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions