BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL SINGLE KIT

    MDR report key: 1972605 · Received January 19, 2011

    Report

    Report Number
    2183502-2010-00665
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Report Date
    December 16, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE TUBING SEPARATED PRIOR TO USE. THERE WAS NO REPORTED PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK