HEARTSINE SAMARITAN PAD 350P
Received Jun 19, 2026 · Event occurred Jun 25, 2025
Report 3004123209-2026-00397 · MDR key 25562845
Device
Generic name
Over-the-counter Automated External Defibrillator
Manufacturer
Heartsine Technologies LtdModel number
SAM 350PCatalog number
350-STR-IT-10
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A SERVICE REPRESENTATIVE PERFORMED EVALUATION OF THE CUSTOMER¿S DEVICE AND OBSERVED BENT LOCATOR PIN ON THE BATTERY-TERMINAL SIDE. THE INVESTIGATION WAS UNABLE TO DETERMINE HOW OR WHEN THE DAMAGE TO THE LOCATOR PIN OCCURRED. THE CUSTOMER WILL BE PROVIDED WITH REPLACEMENT DEVICE. THE CUSTOMER DEVICE WILL BE SCRAPPED.
Description of Event or Problem
THE CUSTOMER CONTACTED HEARTSINE TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS OBSERVED BENT LOCATOR PIN ON THE BATTERY-TERMINAL SIDE. 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.