inforMED
MalfunctionNSA

HeartStart

Received Jul 29, 2026

Report 3030677-2026-100810 · MDR key 50072829

Device

Generic name

Over-the-counter Automated External Defibrillator

Model number

HeartStart HS1

Catalog number

M5066A

Product problems

  • Failure of Device to Self-Test

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It has been reported that the device is failing self-test.