inforMED
MalfunctionMKJ

PHILIPS HeartStart FRx

Received Jul 31, 2026

Report 3030677-2026-100822 · MDR key 50104690

Device

Generic name

Automated External Defibrillators (non-wearable)

Model number

Heartstart FRx

Catalog number

861304

Product problems

  • Failure of Device to Self-Test

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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