HEARTSINE SAMARITAN PAD 350P
Received May 20, 2026 · Event occurred Feb 9, 2026
Report 3004123209-2026-00381 · MDR key 25228276
Device
Generic name
Over-the-counter Automated External Defibrillator
Manufacturer
Heartsine Technologies LtdModel number
SAM 350PCatalog number
350-STR-IT-10
Product problems
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS OBSERVED FAILURE OF +VE TERMINAL POGO-PIN. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
A SERVICE REPRESENTATIVE PERFORMED EVALUATION OF THE CUSTOMER¿S DEVICE AND OBSERVED FAILURE OF +VE TERMINAL POGO-PIN. THE FAILED POGO PIN HAD RESULTED IN A POOR ELECTRICAL CONNECTION BETWEEN THE DEVICE AND PAD-PAK, CAUSING THE VOLTAGE FLUCTUATIONS AND SUBSEQUENT LOW BATTERY FAIL. THIS DEVICE SHALL BE SCRAPPED AND REPLACED.