BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10

    MDR report key: 20571605 · Received October 30, 2024

    Report

    Report Number
    3004123209-2024-00192
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 7, 2025
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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'S INVESTIGATION DETERMINED THE ROOT CAUSE OF THE REPORTED FAULT TO BE CORROSION ON THE PCBA DUE TO STORAGE OUTSIDE OF THE INDICATED CONDITIONS. UPON RECEIPT, NO STATUS INDICATOR WAS OBSERVED FLASHING AND THE DEVICE COULD NOT BE POWERED ON. THIS WAS ATTRIBUTED TO SIGNIFICANT CORROSION ON MULTIPLE COMPONENTS AND CIRCUITRIES. THIS HAD RESULTED IN MULTIPLE FAILURE MODES INCLUDING BUT NOT LIMITED TO SHOCK KEY, RTC FAULTS AND LIKELY DEPLETED THE INSTALLED PAD-PAK, AS PER THE REPORTED FAULT. DUE TO THE EXTENT OF THE CORROSION ON THE PCBA, THE MULTIPLE FAILURE MODES THIS HAD CAUSED, AND THE DAMAGE THIS WOULD HAVE CAUSED TO CRITICAL CIRCUITS, NO FURTHER INVESTIGATION COULD BE CARRIED OUT. FURTHERMORE THE DEVICE HISTORY LOG RECORDED NEGATIVE TEMPERATURES WITH A LOW OF -4.4°C WHICH IS BELOW THE MINIMUM INDICATED TEMPERATURE OF 0°C. THE DEVICE WAS SCRAPPED BY HEARTSINE AND THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S SHOCK BUTTON IS NOT FUNCTIONAL. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY 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'S SHOCK BUTTON IS NOT FUNCTIONAL. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040195 PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) NSA HEARTSINE TECHNOLOGIES LTD SAM 350P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown