BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL DOUBLE KIT

    MDR report key: 2082527 · Received April 28, 2011

    Report

    Report Number
    2183502-2011-00379
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING USE, THE TUBING BECAME DETACHED FROM THE ARTERIAL SIDE OF THE STOPCOCK. NO ADVERSE EFFECT TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL DOUBLE KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL INTERNATIONAL LTD. NA 1206515

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK