BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10223061 · Received July 2, 2020

    Report

    Report Number
    3004123209-2020-00168
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    July 1, 2018
    Report Date
    July 2, 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 WAS 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 10TH JUNE 2018.THE DEVICE WAS RETURNED FOR ISSUING A LOW BATTERY PROMPT DURING OMRON GOODS INWARD TESTING (H045-014-005), WHILE CONNECTED TO A TEST POWER SUPPLY. DESPITE BEING UNABLE TO REPEAT THE FAULT DURING THE INVESTIGATION, THERE WAS AN OBSERVABLE DEFECTIVE DETECTED WITH THE -VE BATTERY TERMINAL POGO PIN. THE -VE POGO PIN HAD FAILED TO SPRING INTO THE NORMAL POSITION AND DID NOT PRESENT A SIGNIFICANT RESISTANCE WHEN PRESSED. THIS DEFECT WOULD ACCOUNT FOR THE LOW BATTERY WARNING, DUE TO AN INTERMITTENT BATTERY TERMINAL CONNECTION WITH THE INSTALLED TEST PAD-PAK INTERFACE. 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 A POLICY OF HEARTSINE TO NOT REFURBISH DEVICES THAT HAVE BEEN RETURNED FROM THE FIELD, THEREFORE THIS DEVICE SHALL BE RETAINED AND REPLACED WITH A NEW HDF-3500. .

    Description of Event or Problem · 1

    DEVICE SERVICE REQUIRED PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687317 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1