inforMED
MalfunctionMJK

HEARTSTART

Received Feb 21, 2025

Report 3030677-2025-000557 · MDR key 21432834

Device

Generic name

Aed

Model number

HEARTSTART HS1

Catalog number

M5066A

Product problems

  • Failure of Device to Self-Test
  • Failure of Device to Self-Test

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST.