BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN PAD 350P

    MDR report key: 24751820 · Received April 1, 2026

    Report

    Report Number
    3004123209-2026-00357
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    November 26, 2025
    Report Date
    April 1, 2026
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE EVALUATED THE CUSTOMER'S DEVICE AND OBSERVED THAT THE DEVICE WOULD NOT POWER ON. IT WAS DETERMINED THAT THE PAD-PAK WAS DEPLETED DUE TO THE DEVICE'S HIGH CURRENT DRAIN. MULTIPLE COMPONENTS WERE MEASURED, REMOVED AND REINSTALLED, INCLUDING MOSFET COMPONENT DESIGNATOR Q35. HOWEVER, AFTER REINSTALLING Q35 THE DEVICE BEGAN TO WORK PROPERLY. THE ROOT CAUSE OF THE PAD-PAK BEING DEPLETED AND UNABLE TO POWER ON THE DEVICE WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE RETURNED DEVICE WAS SCRAPPED BY HEARTSINE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, HEARTSINE OBSERVED THAT THE DEVICE WOULD NOT POWER ON. FAILURE TO POWER ON DEVICE MAY PREVENT OR DELAY DEFIBRILLATION THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819401 HEARTSINE SAMARITAN PAD 350P OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR NSA HEARTSINE TECHNOLOGIES LTD SAM 350P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown