BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT HEART KIT

    MDR report key: 175850 · Received July 2, 1998

    Report

    Report Number
    1518762-1998-00095
    Event Type
    Malfunction
    Date Received
    July 2, 1998
    Report Date
    June 3, 1998
    Manufacturer
    MEDEX
    Product Code
    DRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT LUER LOCK CAME OFF NEAR THE NOVADOME. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT HEART KIT PRESSURE MONITORING SET DRS MEDEX NA 27F241161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN