BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10360659 · Received August 4, 2020

    Report

    Report Number
    3004123209-2020-00242
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    April 1, 2019
    Report Date
    August 4, 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 (B)(6) 2019. UPON RECEIPT THE DEVICE COULD NOT BE POWERED ON, AS PER THE REPORTED FAULT. A CRIMPING ISSUE WAS OBSERVED ON THE +VE BATTERY CABLE, WHICH CONNECTS THE PAD-PAK BATTERY TO THE HDF-3500. THIS HAD RESULTED IN AN INTERMITTENT CONNECTION AND THEREFORE THE INABILITY TO POWER ON THE DEVICE. THE DEVICE WAS SUBJECT TO OUT QAT TESTING AT HEARTSINE ON THE (B)(6) 2019. DURING THIS TESTING, THE DEVICE ISSUED THE FULL SHOCK THERAPY SEQUENCE AND NO FAULT WAS FOUND ON THE UNIT. THE INTERMITTENT NATURE OF THE FAULT WOULD INDICATE THAT THE CONDUCTOR WITHIN THE CABLE HAD BEEN MAKING CONTACT ADEQUATE CONTACT WITH THE CRIMP AT THIS TIME. THE ISSUE WILL BE FURTHER INVESTIGATED UNDER NC (B)(4). 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 WILL NOT SWITCH ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824642 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1