BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN PAD 500P

    MDR report key: 23898100 · Received December 26, 2025

    Report

    Report Number
    3004123209-2025-00734
    Event Type
    Death
    Date Received
    December 26, 2025
    Date of Event
    November 29, 2025
    Report Date
    January 20, 2026
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AT HEARTSINE. THE DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. THE CLINICAL REVIEW OF THE REPORTED EVENT WAS PERFORMED AND IT WAS CONCLUDED THAT THE DEVICE DID PERFORM TO SPECIFICATION THROUGHOUT THIS EVENT. IT CANNOT BE DETERMINED IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT¿S OUTCOME. HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE FOR EVALUATION. WE WILL COMMUNICATE OUR FINDINGS REGARDING THE CAUSE OF THIS EVENT IN OUR FINAL REPORT.

    Additional Manufacturer Narrative · 0

    HEARTSINE CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. HEARTSINE REQUESTS PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE FOR EVALUATION. WE WILL COMMUNICATE OUR FINDINGS REGARDING THE CAUSE OF THIS EVENT IN OUR FINAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER AND THAT SHOCK BUTTON WAS STUCK. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER AND THAT SHOCK BUTTON WAS STUCK. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313012 HEARTSINE SAMARITAN PAD 500P OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 500P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death