BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX LOGICAL LEFT HEART SET

    MDR report key: 1872114 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00451
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    DRS
    PMA / PMN Number
    K790314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE CONTROL SYRINGE WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PT INVOLVEMENT, INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX LOGICAL LEFT HEART SET DRS TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS SMITHS MEDICAL ASD, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK