BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3031900 · Received March 25, 2013

    Report

    Report Number
    1217157-2013-00046
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS,
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT PCO2 RESULT IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PO2 RESULTS FOR A PT SAMPLE DID NOT AGREE WHEN RUN ON TWO DIFFERENT INSTRUMENTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121652 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS, RP405

    Patients

    Seq Age Sex Outcome Treatment
    1