BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERFLASH

    MDR report key: 23413717 · Received October 29, 2025

    Report

    Report Number
    1000165971-2025-00691
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ASICA
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ATTACHED FILES, THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE DEVICE WAS MANUFACTURED IN 2018, SO IT COULD BE A PROBLEM RELATED TO ONE OF THE ELECTRONIC BOARDS, BUT THIS DOES NOT APPEAR IN THE ATTACHED FILES. IF THE REPORTED PROBLEM RECURS, I RECOMMEND THAT YOU SEND THE DEVICE TO THE REPAIR CENTER SO THAT THEY CAN PERFORM A FUNCTIONAL AND RECORDING TEST. PLEASE LET ME KNOW IF YOU WANT ME TO DO IT NOW.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICE WAS CONNECTED AND WORKING DURING THE FULL 7 DAYS, HOWEVER NO ECG WAS RECORDED. THE CLIENT WANTS TO KNOW BASED ON THE FILES IF THE DEVICE MIGHT HAVE A PROBLEM. MEANWHILE THEY PERFORMED A QUICK 10 MIN TEST AND ALL SEEMS NORMAL. THE DEVICE WILL BE USED AGAIN.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICE WAS CONNECTED AND WORKING DURING THE FULL 7 DAYS, HOWEVER NO ECG WAS RECORDED. THE CLIENT WANTS TO KNOW BASED ON THE FILES IF THE DEVICE MIGHT HAVE A PROBLEM. MEANWHILE THEY PERFORMED A QUICK 10 MIN TEST AND ALL SEEMS NORMAL. THE DEVICE WILL BE USED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315076 SPIDERFLASH ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ SPIDERFLASH-T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown