BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAI TRUEVIEW 100 PRO SPECIMEN RADIOGRAPHY SYSTEM

    MDR report key: 19751403 · Received July 15, 2024

    Report

    Report Number
    MW5157304
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 11, 2024
    Manufacturer
    COMPAI HEALTHCARE (SUZHOU) CO.,LTD
    Product Code
    MWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE IS ELECTRICALLY UNSAFE. NEW DEVICE HAS OVER 1800 MICROAMPS LEAKAGE TO GROUND. MFR IS AWARE THEY ARE SELLING ELECTRICALLY UNSAFE PRODUCTS AS THEY ADMITTED THAT OTHER CUSTOMERS HAVE HAD SAME PROBLEM. ALSO SOLD WITH A NON- HOSPITAL GRADE PLUG. AFTER UNIT WARMS UP LEAKAGE CURRENT GOES FROM 450 MICRO AMPS TO OVER 1800 MICRO AMPS. APPEARS TO BE A DESIGN FLAW AND NOT AN EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165472 COMPAI TRUEVIEW 100 PRO SPECIMEN RADIOGRAPHY SYSTEM CABINET, X-RAY SYSTEM MWP COMPAI HEALTHCARE (SUZHOU) CO.,LTD TRUEVIEW 100 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown