BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN PAD 350P

    MDR report key: 25228276 · Received May 20, 2026

    Report

    Report Number
    3004123209-2026-00381
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 20, 2026
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229180 HEARTSINE SAMARITAN PAD 350P OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR NSA HEARTSINE TECHNOLOGIES LTD SAM 350P

    Patients

    Seq Age Sex Outcome Treatment
    1