BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10342773 · Received July 30, 2020

    Report

    Report Number
    3004123209-2020-00222
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    April 12, 2019
    Report Date
    July 30, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE HDF-3500 DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE HDF-3500 PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 17TH OCTOBER 2018. UPON RECEIPT, THE DEVICE WAS FAILING SELF-TESTS DUE TO LOW BATTERY WITH THE RETURNED PAD-PAK INSTALLED, AS PER THE REPORTED FAULT. THE PAD-PAK WAS FURTHER INSPECTED, WHICH REVEALED ONE OF ITS BATTERY CELLS WAS FAILING UNDER LOAD. THE HDF-3500 CURRENT DRAIN AND BATTERY MONITORING CIRCUITRY WERE VERIFIED DURING INVESTIGATION. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS. ADDITIONAL STRESS TESTING WAS THEN CARRIED OUT AT 50°C 95%RH FOR 5 DAYS. THIS COMBINED TESTING EQUATES TO APPROXIMATELY 9.5 YEARS OF NORMAL USE WITHOUT FAULT. AS NO FAULT WAS FOUND ON THE RETURNED HDF-3500 UNIT OR ELSEWHERE ON THE RETURNED PAD-PAK, THE INVESTIGATION CONCLUDES THE FAILURE OF THE PAD-PAK HAD BEEN DUE TO A SINGLE FAILED CELL. INFORMATION FROM THE DEVICE MEMORY SHOWED THE HDF-3500 WAS SUCCESSFULLY INSTALLED ON THE (B)(6) 2019 AND PERFORMED TO SPECIFICATION FOR THREE DAYS, PRIOR TO ISSUING THE FIRST LOW BATTERY WARNING ON THE (B)(6) 2019. IT IS THEREFORE ASSUMED THAT THE CELL HAD INITIALLY FAILED AROUND THIS TIME. DUE TO THE STRESS TESTING CARRIED OUT IN THIS INVESTIGATION, THE DEVICE SHALL BE RETAINED AND REPLACED WITH A NEW HDF-3500.

    Description of Event or Problem · 1

    LOW BATTERY PROMPT HEARD FROM DEVICE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810769 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1