HEARTSINE SAMARITAN PAD 350P
Received Jun 5, 2026 · Event occurred Jan 8, 2025
Report 3004123209-2026-00389 · MDR key 25408089
Device
Generic name
Over-the-counter Automated External Defibrillator
Manufacturer
Heartsine Technologies LtdModel number
SAM 350PCatalog number
350-STR-JA-10
Product problems
- Failure to Power Up
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. UPON EVALUATION, HEARTSINE OBSERVED THAT THE -VE TERMINAL POGO-PIN WOULD FALL INTO ITS BARREL UPON ROTATION OF THE DEVICE. IN THIS STATE THE DEVICE COULD NOT BE POWERED ON VIA THE ON/OFF BUTTON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
HEARTSINE EVALUATED THE CUSTOMER'S DEVICE AND WAS ABLE TO VERIFY THE REPORTED ISSUE. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE AND THE CUSTOMER'S DEVICE WAS SCRAPPED BY HEARTSINE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE FAILURE OF -VE TERMINAL POGO-PIN.