BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE, 360P, 1 PAD-PAK-01, USB, ENGLISH, 360-BAS-CN-10

    MDR report key: 22699333 · Received August 4, 2025

    Report

    Report Number
    3004123209-2025-00210
    Event Type
    Death
    Date Received
    August 4, 2025
    Date of Event
    July 7, 2025
    Report Date
    November 18, 2025
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE HAS REQUESTED THE RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    HEARTSINE BECAME AWARE THERE WAS A PATIENT INVOLVED WHO DID NOT SURVIVE THIS EVENT. SECTIONS A, B, AND H HAVE BEEN UPDATED ACCORDINGLY. HEARTSINE CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. HEARTSINE PERFORMED A CLINICAL REVIEW OF THIS EVENT AND DUE TO A LACK OF DATA IT CANNOT BE DETERMINED IF THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THIS EVENT. HEARTSINE EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. THE PAD-PAK USED DURING THE REPORTED EVENT HAD EXPIRED 37 DAYS PRIOR TO THE DATE OF THE EVENT (JUNE 1, 2025). NO FAULT WAS FOUND ON THE DEVICE DURING INVESTIGATION. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE INVESTIGATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS DEVICE WAS ARCHIVED BY HEARTSINE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED HEARTSINE THE SERIAL NUMBER OF THE DEVICE, SECTION D HAS BEEN UPDATED ACCORDINGLY. HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE AND INVESTIGATION INTO THE DEVICE MALFUNCTION IS PENDING.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT ADMINISTER SHOCKS. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT ADMINISTER SHOCKS. 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 DID NOT ADMINISTER SHOCKS. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353949 PACKAGE, 360P, 1 PAD-PAK-01, USB, ENGLISH, 360-BAS-CN-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEARTSINE TECHNOLOGIES LTD SAM 360P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death