BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT AIR COMPRESSOR

    MDR report key: 20009820 · Received August 21, 2024

    Report

    Report Number
    20009820
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ENDOCLOT PLUS CO.,LTD.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PLACING BATTERIES INTO EQUIPMENT - IT IMMEDIATELY SPARKED - SMALL FLAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353968 ENDOCLOT AIR COMPRESSOR COMPRESSOR, AIR, PORTABLE BTI ENDOCLOT PLUS CO.,LTD. EPAC-2 D122075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown