BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN PAD 360P

    MDR report key: 24814168 · Received April 8, 2026

    Report

    Report Number
    3004123209-2026-00361
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 8, 2026
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING EVALUATION OF THE CUSTOMER'S DEVICE IT WAS OBSERVED FAILURE OF -VE TERMINAL POGO-PIN. THE FAILED POGO PIN HAD RESULTED IN A POOR ELECTRICAL CONNECTION BETWEEN THE DEVICE AND PAD-PAK. THE CUSTOMER'S DEVICE WILL BE SCRAPPED BY HEARTSINE AND THE CUSTOMER WILL BE PROVIDED WITH A REPLACEMENT DEVICE.

    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
    875786 HEARTSINE SAMARITAN PAD 360P AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEARTSINE TECHNOLOGIES LTD SAM 360P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown