BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,360P,PP03,HE,360-STR-HE-10

    MDR report key: 22024642 · Received May 15, 2025

    Report

    Report Number
    3004123209-2025-00149
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 28, 2025
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 EVALUATED THE DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. IT WAS FOUND THERE WAS CORROSION ON THE ON/OFF BUTTON CONTACT PADS, THE UNDERSIDE OF THE ON/OFF BUTTON DOME, ALONGSIDE THE CORROSION ON THE DEVICE SCREWS, MEMBRANE TAIL AND USB CONTACT COLLARS, WHICH INDICATES THAT THE DEVICE HAD BEEN STORED OUTSIDE THE INDICATED CONDITIONS. THE FAULT COULD NOT BE REPLICATED AFTER THE CORROSION WAS CLEARED. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO ENVIRONMENTAL CONDITIONS. THE DEVICE WAS SCRAPPED AND THE CUSTOMER WAS SENT A REPLACEMENT DEVICE. SECTION D1 OF THE INITIAL MEDWATCH REPORT INDICATES: PACKAGE,(B)(4). SECTION D1 OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(4). SECTION D2B OF THE INITIAL MEDWATCH REPORT INDICATES: NSA. SECTION D2B OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: MKJ. SECTION D4 MODEL # OF THE INITIAL MEDWATCH REPORT INDICATES: SAM 350P. SECTION D4 MODEL # OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: SAM 360P. SECTION D4 CATALOG # OF THE INITIAL MEDWATCH REPORT INDICATES: 350-STR-HE-10. SECTION D4 CATALOG # OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 360-STR-HE-10. SECTION D4 GTIN OF THE INITIAL MEDWATCH REPORT INDICATES: (B)(4). SECTION D4 GTIN OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT TURN ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT TURN ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347440 PACKAGE,360P,PP03,HE,360-STR-HE-10 AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 360P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown