MalfunctionNSA
HeartStart
Received Jul 29, 2026
Report 3030677-2026-100807 · MDR key 50072132
Device
Generic name
Over-the-counter Automated External Defibrillator
Manufacturer
Philips North America LlcModel number
HeartStart HS1Catalog number
M5066A
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.