BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL CATH LAB SET

    MDR report key: 1190664 · Received October 2, 2008

    Report

    Report Number
    9616567-2008-00082
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    SMITHS MEDICAL, ASD.
    Product Code
    DRS
    PMA / PMN Number
    K820355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT: 1212106, MANUFACTURED SEPTEMBER 2007. ONE SAMPLE WAS RECEIVED WITH NO VISIBLE DAMAGE OR MANUFACTURING ISSUE THAT WOULD HAVE CONTRIBUTED TO THE REPORT. THE SAMPLE WAS PRIMED AND REPEATEDLY TESTED WITH NO VISIBLE AIR INGRESS NOTED. THE DEVICE HISTORY WAS REVIEWED WITH NO ISSUES NOTED. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED "AIR PROBLEM IN DYE LINE." THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL CATH LAB SET PRESSURE MONITORING SET DRS SMITHS MEDICAL, ASD. NA 1307623

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK