MalfunctionNSA
HEARTSINE SAMARITAN PAD 350P
Received Jun 16, 2026 · Event occurred Jun 2, 2026
Report 3004123209-2026-00395 · MDR key 25516100
Device
Generic name
Over-the-counter Automated External Defibrillator
Manufacturer
Heartsine Technologies LtdModel number
SAM 350PCatalog number
350-BAS-CF-10
Product problems
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HEARTSINE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT ONE OF THEIR DEVICE'S PINS IS PUSHED IN. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.