BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10231864 · Received July 6, 2020

    Report

    Report Number
    3004123209-2020-00185
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    April 12, 2019
    Report Date
    July 6, 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 21ST JUNE 2016. UPON RECEIPT, THE -VE TERMINAL POGO PIN FELT NOTABLY LESS FIRM THAN THE OTHER PINS AND DID NOT PRESENT A SIGNIFICANT RESISTANCE WHEN PRESSED, WHICH INDICATED THE SPRING WITHIN THE PIN HAD FAILED. DESPITE BEING UNABLE TO REPLICATE THE LOW BATTERY WARNINGS OBSERVED IN THE DEVICE MEMORY, MEASUREMENTS TAKEN DURING THE INVESTIGATION CONFIRMED THE FAILURE OF THE POGO PIN. THE FAILED -VE POGO PIN WOULD HAVE RESULTED IN A POOR CONNECTION FROM THE DEVICE TO THE PAD-PAK, LEADING TO VOLTAGE FLUCTUATIONS AND THE SUBSEQUENT LOW BATTERY FAILS, BEGINNING ON (B)(6) 2019. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, LOW BATTERY¿ PROMPT AS PER THE REPORTED FAULT, ALONGSIDE A FLASHING RED STATUS LED. THE POGO PINS ARE CHECKED DURING HDF-3500 LOWER CASE ASSEMBLY (H006-006-187). THE DEVICE ALSO SUCCESSFULLY PASSED THE HDF-3500 FINAL UNIT TEST (H045-014-004) WHILE AT HEARTSINE, THEREFORE THE FAULT WOULD HAVE EITHER HAD TO HAVE OCCURRED AFTER THIS TIME OR WAS INTERMITTENT IN NATURE. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE RETAINED AND REPLACED WITH A NEW HDF-3500.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698445 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1