BEUDAMED
    FDA Adverse Event Other Summary report: N

    M248 BLOOD GAS ANALYZER

    MDR report key: 3071015 · Received April 11, 2013

    Report

    Report Number
    1217157-2013-00060
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K935830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DISCREPANCY IN PCO2 RESULTS IS UNKNOWN. SERIAL # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANCY IN PCO2 RESULTS ON ONE PATIENT SAMPLES IN BETWEEN TWO M248 BLOOD GAS ANALYZERS. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155578 M248 BLOOD GAS ANALYZER BLOOD GAS ANALYZER CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. M248

    Patients

    Seq Age Sex Outcome Treatment
    1