BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 10143156 · Received June 11, 2020

    Report

    Report Number
    3004123209-2020-00126
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    September 24, 2019
    Report Date
    June 11, 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 (B)(6) 2016. UPON RECEIPT, THE DEVICE WOULD NOT ISSUE AUDIO PROMPTS AS PER THE REPORTED FAULT. DAMAGE WAS OBSERVED ON THE INTERIOR SPEAKER CABLE IN THE REGION WHERE THE RIM OF THE UPPER CASE MEETS THE LOWER CASE, INDICATING THAT THE CABLE HAD BEEN DAMAGED DURING PAIRING OF THE TWO CASES AT MANUFACTURE. THE FAILURE OF THE SPEAKER WAS VERIFIED BY MEASUREMENT. THE FAULT COULD NOT BE REPLICATED AFTER REPLACING THE SPEAKER. THIS CONFIRMED A FAILURE OF THE RETURNED SPEAKER. THE FAILURE OF THE SPEAKER DID NOT AFFECT THE UNIT¿S ABILITY TO SUCCESSFULLY DELIVER THE TEST THERAPY SEQUENCE, AS DEMONSTRATED DURING THE INVESTIGATION, AS THE DEVICE CONTINUED TO PROMPT THERAPY VIA THE INSTRUCTIONAL LEDS. INFORMATION FROM HEARTSINE RECORDS AND THE HISTORY LOG FOR THIS DEVICE SHOWED THE DEVICE PASSED OUT QAT ON THE 7TH JULY 2016 AND WAS IN SERVICE FOR OVER 2 YEARS PRIOR TO THE RETURN TO HEARTSINE. IT IS THEREFORE POSSIBLE THAT THE REPORTED FAULT WAS A LATENT FAILURE THAT HAD DEVELOPED OVER TIME DUE TO THE DAMAGED CABLE. AS MULTIPLE MANUAL POWER CYCLES WERE RECORDED FROM THE (B)(6) 2019, IT IS LIKELY THE USER HAD LIKELY BECOME AWARE OF THE FAULT AT THIS TIME. THE ISSUE SHALL BE FURTHER INVESTIGATED UNDER NC.

    Description of Event or Problem · 1

    THE STANDBY DISPLAY IS GREEN. ANNOUNCEMENT DOES NOT FLOW EVEN WHEN THE POWER IS TURNED ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607812 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1