BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAN FLASH

    MDR report key: 1474169 · Received June 23, 2009

    Report

    Report Number
    1423500-2009-00287
    Event Type
    Malfunction
    Date Received
    June 23, 2009
    Date of Event
    June 6, 2009
    Report Date
    June 6, 2009
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    BAXTER REPORTED SMOKE EMITTING FROM THE POWER PLUG ON THE DEVICE SIDE OF THE CLEAN FLASH. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. CALL CENTER STAFF ARRANGED TO SWAP THE INSTRUMENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN FLASH 78KDJ KDJ MED-TECH INC. ATC4538 16701

    Patients

    Seq Age Sex Outcome Treatment
    1