BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPID 1265

    MDR report key: 2913614 · Received January 3, 2013

    Report

    Report Number
    1217157-2012-00076
    Event Type
    Other
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GIG
    PMA / PMN Number
    K960546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE PROBLEM WAS PROBABLY CAUSED BY A CLOT IN THE CO-OXIMETER. CUSTOMER HAS ALSO QUESTIONED WHETHER RESULTS ARE BEING TRANSMITTED CORRECTLY VIA RAPIDCOMM INFO SOFTWARE. CUSTOMER IS SENDING TRACE LOGS FOR REVIEW BY MFR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A HEMOGLOBIN RESULT REPORTED ON A PT IN THE ICU WAS INCORRECT. THE PT REC¿D BLOOD TRANSFUSIONS BASED ON THE TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4194 RAPID 1265 RAPID 1265 GIG SIEMENS HEALTHCARE DIAGNOSTICS RL1265

    Patients

    Seq Age Sex Outcome Treatment
    1